GOOD MORNING.
SO FIRST OF ALL I WOULD LIKE TO
THANK DR. HOLINGSWORTH FOR
EXCELLENT PRESENTATION.
IN THE LAST PRESENTATION OF THE
SESSION WE WOULD LIKE TO BRING
ALL OF OUR DISCUSSIONS LEADING
UP TO THIS POINT ON THE WORK
GROUP AND THE EVIDENCE THAT HAS
BEEN PRESENTED TO THE COMMITTEE
OVER THE PAST COUPLE OF YEARS,
BRING IT ALL TOGETHER AND
DISCUSS CONSIDERATIONS FOR
AGE-BASED RECOMMENDATIONS FOR
PCV 13 AMONG ADULTS.
I WILL SUMMARIZE THE WORK GROUP
DELIBERATIONS SO FAR.
WE'LL PRESENT THE POLICY OPTIONS
THAT WE NARROWED DOWN SO FAR AND
ALSO TALK ABOUT SOME OF THE
CONCERNS AND LIMITATIONS AROUND
EACH.
POLICY QUESTION UNDER
CONSIDERATION IS SHOULD PCV 13
BE ROUTINELY RECOMMENDED TO ALL
ADULTS 65 YEARS OF AGE OR OLDER?
AND THE RATIONALE FOR
CONSIDERING PCV 13 USE AMONG
PERSONS AGED 65 YEARS AND OLDER
AND THE REMAINDER OF THE
PRESENTATION AND DISCUSSION WILL
FOCUS ON THIS AGE GROUP IS
BECAUSE UNIVERSAL RECOMMENDATION
FOR POLYSACCHARIDE VACCINE
TARGETS THIS AGE GROUP.
CAPITA RESULTS ARE FOR THIS AGE
GROUP.
THE WORKING GROUP CONSIDERED
ALTERNATIVE STRATEGIES USING PCV
AND PPSV AS WELL AS AGE BASED
STRATEGY THAT STARTED AGE 50 AS
PRESENTED IN THE PREVIOUS
PRESENTATION.
HOWEVER, ECONOMIC ANALYSIS SHOWS
THAT THE STRATEGIES THAT START
AT AGE 65 ARE FAVORED.
THOSE ARE MORE COST EFFECTIVE
STRATEGIES AS WELL AS HEALTH
BENEFITS ARE INCREASED WHEN WE
CONSIDER THOSE STRATEGIES.
SO IN 2012 WHEN PCV 13 WAS
LICENSED FOR USE AMONG ADULTS WE
CONDUCTED GREAT EVALUATION OF
ALL OF THE EVIDENCE.
AT THAT TIME THE WORKING GROUP
CONCLUDED THAT THE EVIDENCE
QUALITY WAS LOW OF TYPE 3.
THAT WAS BECAUSE WE HAD LIMITED
STUDIES ON EFFICACY AGAINST
INVASIVE DISEASE.
WE HAD ONE TRIAL CONDUCTED.
WE HAD NO DATA ON EFFICACY
AGAINST PNEUMONIA.
THE WORKING GROUP CONCLUDED AND
AGREED THERE WAS UNCERTAINTY ON
MAGNITUDE OF COST EFFECTIVENESS
DUE TO KEY PIECES OF DATA WHICH
WAS EFFICACY AGAINST
NONBACTEREMIC PNEUMONIA.
AT THAT TIME PCV 13 FOR CHILDREN
HAD JUST BEEN INTRODUCED AND WE
HADN'T OBSERVED ANY HERD EFFECTS
AND THERE WAS UNCERTAINTY ON THE
MAGNITUDE TO WHICH PCV 13 WOULD
REDUCE DISEASE BURDEN AMONG
ADULTS.
SO WE MADE A DECISION TO DEFER
THE AGE BASED RECOMMENDATION
UNTIL THE TWO CRITICAL PIECES OF
DATA BECAME AVAILABLE.
WE NOW HAVE EFFICACY DATA FROM
CAPITA.
AND THE RESULTS SHOW THAT THE
VACCINE IS 75% EFFICACIOUS IN
PREVENTING VACCINE TYPE EVASIVE
DISEASE.
IT IS 45% EFFICACIOUS IN
PREVENTING NONBACTEREMIC
PNEUMONIA IN ADULTS 65 AND
OLDER.
WHAT WE WANTED TO DO IS ESTIMATE
WHAT IMPACT WE MIGHT EXPECT
AMONG PERSONS AGE 65 AND OLDER
IN THE U.S.
WE ESTIMATED HOW MANY PERSONS
AGED 65 OR OLDER WOULD NEED TO
BE VACCINATED TO PREVENT A
SINGLE CASE OF IPD OR
VACCINE-BASED COMMUNITY ACQUIRED
PNEUMONIA.
WE USED DATA FROM SURVEILLANCE.
THAT IS 6.5 CASES PER 100,000 OF
VACCINE TYPE DISEASE THAT WE
OBSERVED ACCORDING TO THE MOST
RECENT DATA.
AND WE USED PUBLISHED SOURCES OF
DATA FOR INCIDENTS OF
COMMUNITY-ACQUIRED PNEUMONIA
BOTH INPATIENT AND OUTPATIENT.
I DIDN'T DO ANYTHING.
AND THE RATES ARE PRESENTED HERE
BUT WE OBTAINED THE RATES OF ALL
COMMUNITY-ACQUIRED PNEUMONIA AND
THEN APPLIED THE 10% THAT WAS
MENTIONED IN THE PREVIOUS
PRESENTATION AND THEN ESTIMATE
OF THE PROPORTION OF ALL
PNEUMONIA CAUSED BY PCV 13
SEROTYPES.
NEXT WE APPLIED VACCINE EFFICACY
ESTIMATES FROM CAPITA AND
ESTIMATED NUMBER NEEDED TO
VACCINATE.
FOR COMMUNITY-ACQUIRED PNEUMONIA
1,600 OR 1,100 FOR INPATIENT AND
OUTPATIE ADULTS
NEED TO BE VACCINATED IN ORDER
TO PREVENT A SINGLE CASE OF
INPATIENT OR OUTPATIENT
COMMUNITY-ACQUIRED PNEUMONIA.
IF WE MAKE THE DISCUSSION THEY
ARE INDEPENDENT EVENTS WE CAN
ESTIMATE THAT 650 ADULTS 65 AND
OLDER NEED TO BE VACCINATED TO
PREVENT A SINGLE CASE OF
COMMUNITY-ACQUIRED PNEUMONIA.
WE ASSESS THE QUALITY OF THIS
NEW EVIDENCE WHICH WAS NOT
INCLUDED IN THE PREVIOUS
EVALUATION.
SO FOR THE CRITICAL OUTCOMES OF
INVASIVE PNEUMOCOCCAL DISEASE
EVIDENCE FROM CAPITA WAS
DOWNGRADED FROM TYPE I TO TYPE
II.
THIS WAS DUE TO INDIRECTIVENESS.
THE COMPARSON WAS NO VACCINE.
IN THIS COUNTRY THE STANDARD OF
CARE IS POLYSACCHARIDE VACCINE.
THE STUDY SHOWED EFFICACY RANGES
FROM 50% TO 80%.
THEREFORE WE CAN ASSUME WE WOULD
BE OVERESTIMATING EFFICACY
AGAINST EVASIVE DISEASE.
NEVERTHELESS IT IS A STRONG TYPE
OF EVIDENCE, TYPE II.
FOR PNEUMONIA ALSO BASED ON
CAPITA STUDY RESULTS THE QUALITY
OF EVIDENCE IS OF TYPE I.
NEXT WE UPDATED OVERALL QUALITY
OF EVIDENCE FROM PREVIOUS
ASSESSMENTS.
SO PREVIOUS ASSESSMENTS WE
CONDUCTED EXTENSIVE REVIEW OF
IMUNIGENISITY STUDIES.
WE USED DATA AS A SURROGATE FOR
OUR CLINICAL OUTCOMES.
NOW WE HAVE EVIDENCE FOR
PNEUMOCOCCAL DISEASE AND
PNEUMONIA AND THE OVERALL
QUALITY OF EVIDENCE IS ASSESSED
BASED ON CRITICAL OUTCOMES.
THE LOWEST QUALITY OF EVIDENCE
FOR IPD IS WHAT CONTRIBUTED TO
THE DETERMINATION OF THE OVERALL
EVIDENCE TYPE.
SO THE CONCLUSION IS A STRONG
QUALITY OF EVIDENCE THE ANSWERS
TO THE FOLLOWING FOUR QUESTIONS
ARE CONSIDERED TO DETERMINE
RECOMMENDATION CATEGORY.
I PRESENTED CONCLUSIONS WE
REACHED IN 2012 ALONG SIDE WITH
THE CONCLUSIONS THAT WERE
REACHED IN 2014.
B VERSUS HARM?
THERE IS NO UNCERTAINTY ABOUT
THE BALANCE OF BENEFITS VERSUS
HARMS, HOWEVER THE SHORT TERM WE
HAVE NO UNCERTAINTY ABOUT THE
MAGNITUDE OF THE BENEFITS THAT
ARE EXPECTED.
BUT THE LONG TERM THERE IS
UNCERTAINTY ABOUT THE MAGNITUDE
OF THE EXPECTED BENEFITS DUE TO
INDIRECT EFFECTS.
THERE WAS NO UNCERTAINTY IN
RELATIVE IMPORTANCE ASSIGNED TO
DIFFERENT HEALTH OUTCOMES.
AND IN TERMS OF THE COST
EFFECTIVENESS SHORT TERM THERE
WAS NO UNCERTAINTY THAT BENEFITS
ARE WORTH THE COST.
IT WAS SHOWED IN THE BASE CASE
IN THE PREVIOUS PRESENTATION.
HOWEVER, THE WORK GROUP FELT
THAT THE LONG TERM THERE WAS AN
UNCERTAINTY ABOUT WHETHER THE
NET BENEFITS ARE WORTH THE COST
DUE TO CONTINUED HERD EFFECTS.
WE HAVE UPDATED THE COMMITTEE ON
HERD EFFECTS FROM THE PEDIATRIC
PCV USE LEADING UP TO THIS
MEETING.
AND THE DATA PRESENTED HERE IS
THE MOST RECENT DATA FROM ACTIVE
BACTERIAL SURVEILLANCE WHICH
SHOWS INDIRECT EFFECTS OF PCV 13
USED IN CHILDREN ON DISEASE
BURDEN AMONG ADULTS 65 YEARS OF
AGE AND OLDER CONTINUES TO BE
OBSERVED.
THE BLUE LINE SHOWS REDUCTIONS
OVERALL IN INVASIVE DISEASE.
THESE ARE SIGNIFICANT REDUCTIONS
OBSERVED COMPARED TO PRE-PCV 13
PERIOD.
THE REDUCTION ARE DRIVEN BY PCV
SEROTYPES.
SEROTYPES UNIQUE WITH PCV ARE
SHOWN HERE.
AND REDUCTIONS OBSERVED COMPARED
TO PRE-PCV 13 PERIOD.
WE CONTINUED TO OBSERVE
REDUCTIONS IN PCV 7 SEROTYPES
THROUGH PERIOD OF PCV 13
INTRODUCTION AND POTENTIAL
REDUCTION OBSERVED POST PCV 13
COMPARED TO PRE-PCV 13 PERIOD.
IN TERMS OF INDIRECT EFFECTS OF
STUDIES HAVE
DOCUMENTED THEIR REDUCTIONS IN
NONBACTEREMIC PNEUMONIA
FOLLOWING PCV 7 INTRODUCTIO IN
CHILDREN.
STUDIES WERE CONDUCTED USINGTRA
IMPACT ON ALL CAUSES OF
PNEUMONIA AND NONBACTEREMIC
PNEUMONIA.
WE SHARED THE DATA WITH THE
COMMITTEE.
THE RECENTLY CONDUCTED STUDY
ALSO DOCUMENTED THE INDIRECT
EFFECTS OF PCV 13 USED ON
NONBACTEREMIC PNEUMONIA DISEASE
BURDEN ON ADULTS.
THE STUDY USING ADMINISTRATIVE
DATA HOSPITALIZATION FOR
PNEUMONIA DOCUMENTED 34%
REDUCTION INNONINVASIVE
PNEUMOCOCCAL OR PNEUMONIA
FOL REDUCTI IN CHILDREN.
TO SUMMARIZE WHAT WE KNOW ABOUT
INDIRECT EFFECTS ON PCV 13 USED
ON CHILDREN.
PCV 7 INTRODUCTION LED TO NEAR
ELIMINATION.
THERE IS EVIDENCE OF CONTINUED
DECLINES IN PCV 7 DUE TO HERD
EFFECTS.
INDIRECT EFFECTS OF PEDIATRIC
PCV 13 PROGRAMS HAVE REDUCED THE
PNEUMONIA CAUSED BY PCV 13
TYPES.
IN SUMMARY, I GUESS WHAT THE
DATA SHOWS IS THE EXPECTED
BENEFITS OF USED ON
ADULTS WILL DECLINE LIKELY OVER
TIME.
SO WHAT WE DID IS SIMILAR TO
WHAT WAS PRESENTED IN DR.
HOLINGSWORTH'S PRESENTATION.
HOWEVER, RATHER THAN LOOKING AT
ONE SNAPSHOT IN TIME WE WANTED
TO ESTIMATE THE PCV 13 TYPE
BURDEN AGE 65 AND OLDER IN A
SETTING OF HERD EFFECTS.
WE ESTIMATED THE CASES OBSERVED
TODAY AND THEN PROJECTING BASED
ON PCV 7 EXPERIENCE AND HERD
EFFECTS WAS ESTIMATED NUMBER OF
CASES IN 2015 WHICH COULD BE THE
FIRST YEAR AFTER VACCINE COULD
BE INTRODUCED AND ALSO 2019
WHICH ALSO USES TIME HORIZON
POST PCV 7 WHERE WE HAD THE
EVIDENCE OF INDIRECT EFFECTS
PLUS PCV 7 AND EXTRAPOLATING
FROM POST PCV 7 AND APPLYING TO
2013 RATES.
SO WHAT WE SAW IS THAT IN 2013
AN ESTIMATED 2,600 CASES OF
INVASIVE PNEUMOCOCCAL DISEASE
DUE TO PCV 13 TYPE IS OBSERVED
IN THE U.S.
AND IN TERMS OF TOTAL
COMMUNITY-ACQUIRED PNEUMONIA
CASES OVER 140,000 CASES ARE
ESTIMATED TO BE OBSERVED IN
2013.
IN 2015 WE APPLIED A 20%
REDUCTION DUE TO HERD EFFECTS.
THIS IS BASED ON POST-PCV 7
EXPERIENCE.
AND THE NUMBER OF CASES IS
REDUCED SLIGHTLY TO 2,000
INVASIVE PNEUMOCOCCAL DISEASE
AND FOR A TOTAL CAP OVER 100,000
CASES ARE OBSERVED.
AND IN 2019, AGAIN, USING THE
PROJECTED HERD EFFECTS WE APPLY
86% REDUCTION DUE TO HERD
EFFECTS.
YOU CAN SEE THE NUMBER OF CASES
OF VACCINE TYPE IS GREATLY
REDUCED TO ALMOST 400 FOR
INVASIVE PNEUMOCOCCAL DISEASE
AND CLOSE TO 20,000 FOR TOTAL
COMMUNITY-ACQUIRED PNEUMONIA.
SO THIS JUST SHOWS HOW THE
DISEASE WOULD CHANGE DUE TO HERD
EFFECTS ALONE.
WHAT WE WANTED TO DO NEXT IS
APPLY THE DIRECT EFFECTS OR
POTENTIAL DIRECT EFFECTS FROM
PCV 13 USE IN THE U.S. IF WE
WERE TO INTRODUCE THE VACCINE IN
2014.
SO WE USED THE EFFICACY ESTIMATE
FROM CAPITA FOR IPD AND FOR
NONBACTEREMIC PNEUMONIA.
WE APPLIED THEM TO THE PROJECTED
CASES EXPECTED IN 2015 BASED ON
HERD EFFECTS, INCORPORATING 20%
REDUCTION IN VACCINE TYPE
DISEASE.
AND ON TOP OF THAT WE CONSIDERED
WHAT WOULD BE A REASONABLE
COVERAGE ESTIMATE FOR PCV IN THE
FIRST YEAR AFTER THE VACCINE IS
INTRODUCED.
AND WE USED LARGELY PPSV
EXPERIENCE AND COVERAGE AFTER
THE RECOMMENDATIONS MADE AND
SEVERAL YEARS FOLLOWING
RECOMMENDATION.
SO FOR 2016 WE USE A 10%
COVERAGE ESTIMATE AND 5% TO 30%
AND ESTIMATED AROUND 160 IPD
CASES WOULD BE PREVENTABLE.
FOR TOTAL COMMUNITY-ACQUIRED
PNEUMONIA AROUND 5,000 CASES
WOULD BE PREVENTABLE.
NEXT FOR 2019, AGAIN, TAKING
INTO ACCOUNT WITH THE DISEASE
BURDEN WOULD BE CONSIDERING THE
86% REDUCTION DUE TO HERD
EFFECTS, APPLYING DIRECT EFFECTS
FROM PCV 13 USE AND IN THIS CASE
TAKING HIGHER COVERAGE WHICH IS
30% COVERAGE FOR PCV AND RANGING
FROM 20 TO 60.
THE 30% WASN'T EXACTLY MADE UP.
WE USE THE PPSV EXPERIENCE.
THE LARGEST ANNUAL INCREMENT
THAT HAS BEEN OBSERVED
HISTORICALLY FOR POLYSACCHARIDE
VACCINE ANNUAL INCREMENT IS
3.5%.
ON AVERAGE 1% INCREASE OBSERVED.
WE USE THE MORE LIBERAL APPROACH
AND APPLY THE 3.5%.
IF WE TAKE THE 3.5% ANNUAL
INCREASE WE SHOULD EXPECT
COVERAGE FROM 2015 TO 2019 TO GO
UP TO 25% TO 30%.
THAT IS WHY WE USE IT AS A BASE
COVERAGE AND WE USE THE COVERAGE
CLOSER TO WHAT WE HAVE FOR
POLYSACCHARIDE VACCINE NOW.
BUT YOU CAN SEE THAT EVEN IF WE
TRIPLE THE COVERAGE FROM 2015 TO
2019 THE NUMBER OF CASES
PREVENTABLE IS ALMOST HALF OF
WHAT WE HAVE IN 2015.
SO 80 CASES FOR INVASIVE
PNEUMOCOCCAL DISEASE AND 2,600
CASES OF TOTAL
COMMUNITY-ACQUIRED PNEUMONIA.
SO AS YOU CAN SEE HERD EFFECTS
ALONE ARE EXPECTED TO REDUCE THE
DISEASE BURDEN AND LONG TERM THE
NUMBER OF CASES PREVENTABLE
THROUGH DIRECT PCV USE AMONG
ADULTS.
SO TO SUMMARIZE THE PRESENTED
EVIDENCE OF DISCUSSION SO FAR
STRONG QUALITY TYPE II EVIDENCE
TO SUPPORT USE IN ADULTS.
PCV 13 IS SAFE FOR USE AMONG
ADULTS.
IT IS EFFICACIOUS IN PREVENTING
INVASIVE DISEASE.
VACCINE PREVENTABLE DISEASE
BURDEN IS STILL REMAINING AMONG
ADULTS 65 AND OLDER.
ADDING A DOSE OF PCV 13 IS A
COST EFFECTIVE STRATEGY AND
PREVENTS ILLNESS AMONG ADULTS 65
AND OLDER.
HOWEVER, HERD EFFECTS WILL
CONTINUE TO REDUCE PCV 13 TYPE
BURDEN AND LIMIT THE UTILITY OF
PCV 13 USE AMONG ADULTS IN THE
LONG TERM.
SO I WANTED TO PRESENT THE TWO
POLICY OPTIONS THAT ARE
CURRENTLY UNDER CONSIDERATION BY
THE WORK GROUP.
SO THE FIRST OPTION CONSIDERS
ADDING A DOSE OF PCV 13 AT AGE
65 TO CURRENT RECOMMENDED
REGIMENT.
IN OTHER WORDS, IT WILL BE A
DOSE OF PCV 13 AT AGE 65 OR
LATER FOLLOWED BY A DOSE OF
POLYSACCHARIDE VACCINE AND
CONSIDERED KEEPING
RECOMMENDATIONS FOR USE
UNCHANGED.
THE SECOND OPTION CONSIDERS
REPLACING A DOSE OF PPSV AT AGE
65 WITH A DOSE OF PCV 13.
A DOSE OF PCV 13 GIVEN AT AGE 65
AND RISK BASED RECOMMENDATIONS
WILL REMAIN UNCHANGED.
BASED ON MODEL ESTIMATES
PREVENTS INVASIVE DISEASE AND
PNEUMONIA.
THE WORK GROUP FELT AND COMMENTS
RECEIVED THE PNEUMOCOCCAL
RECOMMENDATIONS ARE ALREADY VERY
COMPLEX.
BASED ON THE QUESTIONS THAT WE
RECEIVED IN TERMS OF PROVIDERS
ASKING US WHAT TO DO WITH
INDIVIDUAL PATIENTS, THAT IS THE
FEEDBACK WE GET THAT
RECOMMENDATIONS ARE VERY
COMPLEX.
SO THE WORK GROUP MEMBERS, SOME
SAID OPTION ONE WOULD ADD AN
EXTRA LAYER OF COMPLEXITY TO THE
RECOMMENDATION AND POTENTIALLY
WOULD IMPACT THE RECOMMENDATION.
THE SECOND OPTION DOES NOT ADD
AN EXTRA LAYER OF COMPLEXITY
BECAUSE IT IS REPLACING DOSE
WITH PCV HOWEVER AS YOU SAW IN
THE PREVIOUS PRESENTATION BASED
ON OUR ASSUMPTIONS OF EFFICACY
AGAINST POLYSACCHARIDE VACCINE
AND ALSO THE SEROTYPE COVERAGE
PROVIDED BY THE POLYSACCHARIDE
VACCINE IT MAY LEAD TO
ADDITIONAL INVASIVE PNEUMOCOCCAL
DISEASE CASES.
SO DISCUSSIONS ARE STILL ON
GOING BECAUSE INTERVALS SHOULD
BE DEFINED AS WELL AS
RECOMMENDATIONS FOR ADULTS WHO
HAVE PREVIOUSLY RECEIVED
POLYSACCHARIDE VACCINES OR
CONJUGATE VACCINE WHICH IS
CURRENTLY RECOMMENDED FOR
ADULTS.
SO AS YOU SAW WE CONSIDERED
SIMPLIFIED STRATEGIES THAT LOOK
LIKE AGE-BASED RECOMMENDATION
ONLY WITH PCV AND REMOVING PPSV
AND KEEPING ONLY AGE-BASED
STRATEGIES AND REMOVING
RISK-BASED STRATEGIES.
ALL OF THE STRATEGIES THAT DROP
POLYSACCHARIDE VACCINE WHETHER
IT IS RISK-BASED RECOMMENDATION
OR FROM THE SEQUENCE POTENTIALLY
CAN LEAD TO ADDITIONAL CASES OF
INVASIVE DISEASE EVEN THOUGH
SOME OF THEM WERE MORE COST
EFFECTIVE THAN OTHERS BUT MOST
OF THE AGE-BASED STRATEGIES WERE
DOMINATED, IN OTHER WORDS, THEY
LED TO HIGHER COSTS AND WORSE
HEALTH OUTCOMES.
SO WHAT ARE DESIRED
CHARACTERISTICS?
WE SEE PCV 13 LEADS TO 75%
EFFICACY AGAINST IPD AND
NONBACTEREMIC PNEUMONIA.
ADEQUATE COVERAGE OF DISEASE
CAUSING SEROTYPES.
WE KNOW IN THE SHORT TERM THE
STRATEGIES WE ARE CONSIDERING
WITH PCV THERE IS AN ADEQUATE
COVERAGE AND THERE IS STILL
VACCINE PREVENTABLE BURDEN
REMAINING.
IN THE LONG TERM THE HERD
EFFECTS MIGHT THAT
BALANCE AND RESULT IN A SMALLER
FRACTION OF VACCINREVENTABLE
DISEASE BURDEN REMAINING.
RECOMMENDATION THE OMPLEXITY OF
NEW AGE-BASED RECOMMENDATION
COULD PROVIDE AN OPPORTUNITY TO
SIMPLIFY THE RECOMMENDATION.
SO FAR THE POLICY OPTION THAT WE
NARROWED DOWN TO DO NOT ALLOW
FOR THAT SIMPLIFICATION.
SOME WORK GROUP MEMBERS HAD
CONCERNS ABOUT IMPLEMENTATION
ISSUES AROUND THOSE POLICY
OPTIONS.
IT WOULDN'T BE BAD TO HAVE A
COST EFFECTIVE INTERVENTION.
AT LEAST SHORT TERM WE SHOWED
SOME OF THE STRATEGIES ARE COST
EFFECTIVE.
BUT IN A SETTING OF REALIZED
HERD EFFECTS THE SAME STRATEGIES
ARE NO LONGER COST EFFECTIVE.
SO TO SUMMARIZE THE WORK GROUP
SO FAR.
IN THE LONG TERM CONTINUED HERD
EFFECTS MAY LIMIT THE UTILITY OF
THE UNIVERSAL PCV 13
RECOMMENDATION.
POLICY OPTIONS UNDER
CONSIDERATION CURRENTLY BY THE
WORKING GROUP ADD COMPLEXITY TO
CURRENT RECOMMENDATIONS IN
PLACE.
WE NEED TO CONSIDER INTERVALS
BETWEEN PCV 13 AND PPSV AND
CONSIDER PREVIOUS PCV 13 AND
PPSV HISTORY.
THE WORK GROUP WILL CONTINUE
DELIBERATIONS TO DRAFT LANGUAGE
ADDRESSING CONCERNS AROUND
COMPLEXITY OF CURRENT
PNEUMOCOCCAL RECOMMENDATIONS.
ME RESPIRATORY
SEASON IS APPROACHING.
AND THERE AN OPPORTUNITY TO
PREVENT CASES DURING THE
YEAR.
AND A TIMELY IMPLEMENTATION OF
THE POTENTIAL RECOMMENDATIONS TO
BE TIMELY BEFORE THE NEXT SEASON
MAY REQUIRE A DECISION BEFORE
THE OCTOBER MEETING.
UNFORTUNATELY, BECAUSE OF THE
TIMING WHEN WE GOT THE CAPITA
RESULTS AND THE AMOUNT OF TIME
THAT THE WORK GROUP HAD TO
DELIBERATE BEFORE THIS MEETING
THE TIMING FOR THE NEXT
RESPULATORY SEASON MAY NOT BE
REPUTABLE.
THE WORK GROUP WILL CONTINUE
REFINING POLICY OPTIONS AND
WOULD LIKE TO SEEK INPUT FROM
THE COMMITTEE ON THE FOLLOWING.
WE PRESENTED TWO POLICY OPTIONS
THAT WE HAVE NARROWED DOWN SO
FAR AND PRESENTED SOME OF THE
LIMITATIONS AND CONCERNS RAISED
BY WORK GROUP MEMBERS RELATED TO
THE POLICY.
SO THE QUESTION IS, ARE THERE
CONCERNS THAT THE COMMITTEE HAS
OR ADDITIONAL CONCERNS ABOUT THE
PROPOSED POLICY OPTIONS?
WE EXPLAINED AND QUANTIFIED THE
EXPECTED INDIRECT EFFECTS AND
POTENTIAL IMPACTS ON REMAINING
VACCINE PREVENTABLE DISEASE
BURDEN.
HOW SHOULD THE EXPECTED DECLINE
IN UTILITY RECOMMENDATION
INFLUENCE PCV 13 RECOMMENDATION?
AND GIVEN POTENTIAL TIME LIMITED
UTILITY HOW FEASIBLE WOULD IT BE
TO HAVE A TIME LIMITED
RECOMMENDATION?
AND I LEAVE YOU WITH THESE
QUESTIONS ON THIS SLIDE AND OPEN
IT FOR DISCUSSION.
THANK YOU VERY MUCH.
OPEN IT UP FOR DISCUSSION.
THANK YOU FOR A REALLY
EXCELLENT PRESENTATION.
I HAVE TWO QUESTIONS.
ONE IS A PRACTICAL QUESTION AND
ONE IS MORE THEORETICAL.
THE PRACTICAL QUESTION HAS TO DO
WITH VACCINE SEQUENCE AND
SCHEDULING.
I WAS WONDERING IF THERE ARE ANY
EFFICACY DATA ON SIMULTANEOUS
ADMINISTRATION OF PPSV PCV SEQ
ORDER YOU CAN DRAW ON?
THAT IS THE FIRST QUESTION.
>> AM I WAITING FOR THE SECOND
QUESTION?
>> MAYBE DO THAT ONE FIRST AND
THEN I WILL COME TO THE SECOND.
>> WE HAVE NO EFFICACY DATA WITH
CLINICAL EFFICACY DATA ON
SEQUENTIAL ADMINISTRATION.
THE STUDIES THAT WERE USED FOR
LICENSURE DID LOOK AT SEQUENCE
OF PCV 13 FOLLOWED BY PPSV AND
LOOKED AT THE SEQUENCED OR PCV
13 AMONG NAIVE ADULTS AND ADULTS
WHO PREVIOUSLY RECEIVED PPSV
VACCINE.
SO THAT WAS THE DATA THAT
ACTUALLY CONTRIBUTED TO OUR
RECOMMENDATION FOR IMMUNEO
COMPROMISED ADULTS AND IT SEEMS
TO BE A MORE OPTIMAL WAY RATHER
THAN THE OTHER WAY AROUND.
IN TERMS OF INTERVALS THERE IS
LIMITED DATA EVALUATING WHAT
OPTIMAL SHOULD BE BUT BASED IT
ON EVIDENCE FROM STUDIES
AVAILABLE THAT SUGGESTED THAT
THERE ARE CERTAIN INTERVALS THAT
ARE ACCEPTABLE.
I THINK THAT IS THE DISCUSSION
THAT THE WORK GROUP WILL HAVE
RIGHT NOW FOR IMMUNOCOMPETENT
ADULTS.
ON THIS LIMITED UTILITY
ISSUE, I GUESS THE QUESTION
REALLY IS ARE THERE CREATIVE
WAYS TO MONITOR THE DECLINE IN
UTILITY EITHER BY LOOKING AT CAP
IN INVASIVE DISEASE IN 50 TO 65
YEAR AGE GROUP OR LOOKING AT THE
UNIMMUNIZED GROUP OF INDIVIDUALS
OVER THE AGE OF 65?
IT'S NOT PERFECT BUT ARE THOSE
POSSIBILITIES AND IS IT
SOMETHING YOU WOULD PROPOSE
GOING FURTHER RATHER THAN JUST
TIME LIMITED RECOMMENDATION TO
ACTUALLY HAVE SOME DATA?
>> I THINK THOSE ARE ALL VERY
GOOD IDEAS.
I THINK GOING FORWARD IF WE
IMPLEMENT AN AGE-BASED STRATEGY
FOR 65 AND OLDER IT WILL BE VERY
DIFFICULT TO TEASE APART DIRECT
VERSUS INDIRECT EFFECTS.
FOR YOUNGER GROUPS IT MAY BE
EASIER F
EASIER.
THERE WILL BE A MIXTURE OF
EFFECTS.
THAT IS ONE GOOD SUGGESTION.
DR. MOORE.
>> THANKS.
AT THE RISK OF ASKING FOR A
WHOLE NEW WAY OF LOOKING AT IT,
IN TERMS OF SIMPLICITY HAVE
AN AGE 60 PLATFORM WITH ROSTER
VACCINE AND 65 FOR PCV 13.
I WAS WONDERING IF THE
LOOK FOR LOOKING AT AGE 60 TO
PCV 13 AND 65 AND 23 WITH NO
ADVANTAGE OF GETTING PCV 13
FIRST.
THAT EXACT STRATEGY WAS NOT
CONSIDERED.
THE CLOSEST IS WHAT WAS
PRESENTED AT AGE 50 AND THEN AT
65.
I DON'T KNOW IF HE CAN DO
CALCULATIONS IN HIS HEAD OF WHAT
THE IMPACT IS GOING TO BE BUT
THAT IS SOMETHING WE CAN
EXPLORE.
I WILL FOLLOW UP WITH THAT.
IN TERMS OF IMPLEMENTATION USING
THINGS THAT CLINICIANS ARE USED
TO WE IN A VERY POOR MANNER
ATTEMPT TO PROVIDE ZASTER
VACCINE AT AGE 60.
THERE ARE ACTUAL POINTS IN TIME
FOR THE GROUP TO GET VACCINATED.
THE THOUGHT OF TRYING TO GET
SOMEBODY IN FOR A PCV 13 AND
THEN FOLLOW IT UP IN EIGHT WEEKS
IS VERY IMPRACTICAL IN REAL
LIFE.
HAVING SOMETHING AS YOU
SUGGESTED THERE WOULD BE KIND OF
WORTH WHILE TO CONSIDER.
OTHER QUESTIONS?
LL OF THE MODELS, WHATIS SO
CAN YOU PREDICT ABOUT INDIRECT
EFFECTS SHOULD THE SCHEDULE FOR
CHILDREN CHANGE?
>> SO I THINK THAT IS ONE THING
WE CONSIDERED WHEN WE EVALUATED
EVIDENCE FOR THE REDUCED
SCHEDULES FOR CHILDREN AND THE
DATA THAT WE HAVE IS FROM
COUNTRIES THAT HAVE USED THE
REDUCED SCHEDULE AND THAT HAVE
SHOWN EVEN WHEN THEY -- I'M NOT
TALKING ABOUT SWITCHING FROM ONE
SCHEDULE TO ANOTHER -- COUNTRIES
THAT INTRODUCED FROM BEGINNING
THREE DOSE SCHEDULE FOR CHILDREN
THEY OBSERVED HERD EFFECTS VERY
SIMILAR TO WHAT THE U.S. DATA
SHOWS.
I RECOGNIZE THAT THERE IS A
LOT OF UNCERTAINTY ABOUT WHAT
THE NEXT FEW YEARS WILL LOOK
LIKE IN TERMS OF THE HERD
EFFECTS AND THERE HAS BEEN AN
ATTEMPT TO USE THE TRAJECTORY
THAT WE SAW FOLLOWING THE 2000
IMPLEMENTATION OF THE 7 VACCINE.
I WANTED TO POINT OUT WHEN THE
CONJUGATE VACCINE WAS INTRODUCED
IT TOOK A WHILE TO GET COVERAGE
ELEVATED IN YOUNG CHILDREN
WHEREAS WHEN WE SWAPPED THE 7
WITH THE 13 WE ALREADY HAD
PRETTY HIGH COVERAGE AND THE
COMMITTEE RECOMMENDED A FIFTH
DOSE IN THE OLDER KIDS.
WHILE CATCH UP WASN'T PERFECT A
LOT OF CHILDREN UNDER 5 GOT A 13
PROTECTION PRETTY QUICKLY
COMPARED TO THE FIRST FIVE TO
SEVEN YEARS OF THE 7 ERA.
WE ARE JUST HITTING 80% FOR
THOSE COVERAGE NOW.
THE GENTLEMAN BACK WITH THE
MICROPHONE.
I WOULD LIKE TO CONTRIBUTE A
LITTLE BIT ABOUT THE DISCUSSION
DIRECT EFFECT.
THE FIRST TWO POINTS I WOULD
HOW TO MONITOR T ABOUT A
UNDIRECT EFFECTS.
THE FIRST THING I WOULD LIKE TO
HIGHLIGHT IS THAT NO MATTER THE
STUDY WE HAVE DONE MEASURING THE
PROPORTION OF 13 SEROTYPE
CONTRIBUTING TO
COMMUNITY-ACQUIRED PNEUMONIA
STUDIES WERE IN NORTH AMERICA.
IT WAS MENTIONED BEFORE IN A
MATURE PROGRAM THE PROPORTION OF
THE SEVEN SEROTYPES INCLUDED IN
THE DATA THAT WAS PRESENTED 1147
WAS AROUND 25%.
SO THIS IS 14 YEARS AFTER
INTRODUCTION OF PCV 7.
I'M NOT NECESSARILY SURE YOU CAN
EXTRAPOLATE WHAT YOU ARE SEEING
WITH IPD TO WHAT WE ARE SEEING
WITH COMMUNITY-ACQUIRED
PNEUMONIA.
I THINK THAT IS IMPORTANT
BECAUSE WE SEE A PERSISTENT
DISEASE.
I THINK THE SECOND POINT THAT
PERHAPS WE NEED TO BE A LITTLE
BIT CAUTIOUS IS TO EXTRAPOLATE
WITH WHAT WE HAVE SEEN.
SEROTYPE 1 AND SEROTYPE 5 ARE
COVERING FOR A VERY SHORT TIME.
SO THE IMPACT ON HERD EFFECTS
MAY NOT BE SIMILAR TO THE SEVEN
SEROTYPES.
FOR SEROTYPE 3 WE ARE SEEING
PROTECTION OF SOME EVIDENCE AS
WE HAVE SEEN WITH CAPITA AND THE
CASE CONTROLLED IN THE PREVIOUS
COMMITTEE.
WE ARE NOT SEEING THAT IMPACT ON
COVERAGE.
SO I'M CAUTIONING.
I THINK JUST TO COMPLIMENT A
LITTLE BIT COMMENT ABOUT HOW TO
MONITOR IT SEEMS WE HAVE A TOOL
TO MONITOR.
SO THE REASON WHY ALL OF THESE
MODELS HAVE LOOKED AT THE 10% IS
BECAUSE WE WERE ABLE TO MEASURE
THE PROPORTION OF THE 13
SEROTYPES THAT CONTRIBUTE TO
COMMUNITY-ACQUIRED PNEUMONIA IN
THE UNITED STATES.
WE HAVE THAT, TOO.
WE ARE CONTINUOUSLY MONITORED.
WE WORK AS WE OFFER TO TEST IT
IN THE STUDY.
WE CAN CONTINUE TO MONITOR OVER
TIME WHAT IS THE PROPORTION OF
THOSE 13 SEROTYPES AND HOW THAT
70 IS REDU-- ACTIVITY IS REDUCE
NOT REDUCED.
WE SAW 11% TO 13.6%.
I THINK WE NEED TO BE CAUTIOUS.
BUT WE HAVE THE UADC AND SEEING
REDUCTION.
FOR COMMUNITY-ACQUIRED PNEUMONIA
WE CAN MONITOR OVER TIME.
WE OFFER THIS TO ANY
INVESTIGATOR WHO WOULD LIKE TO
MONITOR AND WILL CONTINUE TO DO
SO.
>> THANK YOU.
CAN I RESPOND TO -- MAKE A
COMMENT ABOUT WHAT WAS MADE
RELATED TO THE PERCENT
DISTRIBUTION OF SEROTYPE FOR
COMMUNITY-ACQUIRED PNEUMONIA
VERSUS IPD.
I THINK IT WAS MENTIONED 25% OF
SEROTYPES ARE DUE TO PCV 7
SEROTYPES.
PCV 7 SEROTYPES FOR CAP THAT
NEEDS TO BE EXPLAINED.
IS 25% OUT OF THE 10% THAT IS
ALL PCV 13 TYPES WHICH
TRANSLATES TO AROUND 2% OF ALL
CAP WHICH IS DUE TO THOSE 7
SEROTYPES.
WE ALSO TOOK A LOOK AT THE IPD
DATA IN A SIMILAR SESSION
LOOKING AT PERCENT DISTRIBUTION.
IT IS A VERY SIMILAR PICTURE
WITH WHAT WE SEE WITH INVASIVE
DISEASE.
IT IS NOT DIFFERENT IPD VERSUS
COMMUNITY-ACQUIRED PNEUMONIA.
WHEN WE LOOK AT PERCENT
DISTRIBUTION IT DOESN'T GIVE THE
FULL PICTURE OF HOW RATES ARE
CHANGING.
AS I SHOWED IN ONE OF THE SLIDES
THE PCV 7 RATES CONTINUE TO
DECLINE THROUGH PCV 13 EVEN
THOUGH PERCENT DISTRIBUTION
REMAINS THE SAME.
THAT IS ONE THING I WANTED TO
SAY BECAUSE PERCENT DESCRIPTIONS
DON'T GIVE THE FULL PICTURE.
AND SECOND COMMENT WAS RELATED
TO THE DIFFERENT HERD EFFECTS
OBSERVED DEPENDING ON SEROTYPE
IN PCV 13.
WE TOOK THAT INTO ACCOUNT IN ALL
OF THE ANALYSIS THAT WE LOOKED
AT THE SNAPSHOT OF TIME POST PCV
7 WHICH WAS 2003 THROUGH 2009.
THAT IS NOT THE FULL HERD
EFFECTS OBSERVED.
SO AFTER THAT PERIOD PRETTY MUCH
CONSIDER PLATEAU WHICH KIND OF
ASSUMES THAT MAYBE SOME
REMAINING DISEASE WILL BE
PERSISTING.
AND SO JUST TO QUALIFY IT WAS A
CONSERVATIVE APPROACH TAKING
INTO ACCOUNT THERE ARE
DIFFERENCES BY SEROTYPE.
>> I JUST WANT TO FOLLOW UP ON
THAT.
THE OBSERVATION IS THAT ABOUT 3%
OF THE COMMUNITY-ACQUIRED
PNEUMONIA IS CURRENTLY PCV
TYPES.
THE HERD EFFECTS THAT YOU HAVE
APPLIED TO 2019 ASSUMES THAT THE
PCV 13 TYPES GOES DOWN TO 1.4%,
86% REDUCTION TO 1.4%.
SO WHAT YOU ARE ASSUMING IS THAT
FOR THE PCV 13 TYPES IN SIX
YEARS YOU ARE GOING TO GO DOWN
BELOW WHERE WE ARE WITH THE PCV
7 TYPES 14 YEARS AFTER
PRODUCTION.
WE DON'T REALLY UNDERSTAND WHAT
IS GOING ON.
COMMUNITY-ACQUIRED PNEUMONIA
APPEAR TO BE A LITTLE DIFFERENT.
WE HAVE TO BE CAREFUL ABOUT HOW
MUCH INDIRECT EFFECT.
I THINK I AGREE IT IS DIFFICULT
TO SEE DIRECT AND INDIRECT.
NOT ALL OF THE POPULATION WILL
BE VACCINATED.
THERE WILL BE COOL STUDIES IF WE
DO THAT.
I JUST WANTED TO BALANCE THE
LEVELS.
THANKS.
THANK YOU.
>> THANK YOU VERY MUCH.
FIRST I WANT TO ACKNOWLEDGE THE
HOURS OF THE WORK GROUP AND
MODEL BECAUSE THIS IS NOT AN
EASY TASK.
I THINK THE SITUATION IS
BRIGHTER THAN THE MODEL SHOWS
FUNDAMENTALLY BECAUSE THE 23
VACCINE HAS GREATER EFFICACY
THAN SHOWN.
IF YOU FOLLOW REFERENCE PROVIDED
BACK TO SOURCE REFERENCES IT
COMES FROM THREE OLD STUDIES
THAT LARGELY RELIED ON SPUTUM
ANALYSIS, SMALL STUDIES ONE DREW
BLOOD IN SIX OF THE 200 CASES.
ONE WAS FROM HOSPITALIZED
PNEUMONIA CASES TO SEE IF THEY
GOT RE-INFECTED.
I WOULD SAY NOT GENERALIZABLE.
WE SHOULD USE FOR THE 23 VALENT
VACCINE THE ESSAYS AVAILABLE.
49 OF THE CASES IN ONE STUDY OF
PNEUMONIA CASES WERE POSITIVE.
ONLY THREE WERE FROM BLOOD
CULTURE DIAGNOSIS.
SO I THINK IT IS 64% EFFICACY IS
IN STARK CONTRAST TO 0% EFFICACY
IS PART OF THE SENSITIVITY
ANALYSIS SHOULD AT LEAST BE THAT
WAY THIS TIME AND THE CAPITA
STUDY NOT RANDOMIZED.
SOME OF THE SLIDES YOU HAVE SEEN
HAVE LOOKED AT 13 TYPE DISEASE
ONLY AS IF THAT IS ALL THE
DISEASE THERE IS.
AND YOU KNOW WHERE THERE ARE 90
AND THE 23 NON13 SEROTYPES ARE
NOW ACCOUNTING FOR 30% TO 40% OF
U.S. ADULT IPD, MORE THAN THE 13
TYPE ALREADY.
AND SO I AM CONFIDENT THE ACIP
IS NOT GOING TO LEAVE AMERICAN
ADULTS VULNERABLE TO IPD AND
PNEUMONIA FROM THE 23 NON13
TYPES.
SO I WOULD ASK THAT THE MODEL BE
REASSESSED IN TERMS OF
ASSUMPTIONS.
YOU WILL AT LEAST HAVE TO ADJUST
COST PER DOSE.
I WOULD ASK THAT THE COMMITTEE
CONSIDER MAXIMIZING THE NUMBER
OF SEROTYPES THAT ARE TARGETED
TO PROTECT AMERICAN ADULTS.
THANKS.
>> THANK YOU.
AT THIS POINT I THINK JUST TO
KEEP ON TOPIC I AM GOING TO ASK
BOB AND VIRGINIA TO COME UP TO
THE MICROPHONE.
LIMIT YOUR COMMENTS TO THREE
MINUTES.
STATE YOUR ASSOCIATIONS AND ANY
CONFLICT OF INTEREST.
GOOD MORNING.
NATIONAL ASSOCIATION OF
NUTRITION.
NO CONFLICTS.
WE SERVE HUNDREDS OF THOUSANDS
OF SENIORS EVERY DAY PROVIDING
NUTRITION AND NUTRITION
EDUCATION.
OUR GOAL IS TO KEEP SENIORS
INDEPENDENT.
WE ARE HERE TODAY TO URGE A
BROADER USE OF PNEUMOCOCCAL
VACCINE IN ADULTS, ESPECIALLY
OLDER ADULTS AND CONSIDERING
LOWERING THE AGE OF OLDER ADULTS
TO 60 TO MATCH THE AGE OF
ELIGIBILITY AT OUR PROGRAMS AND
TO START RAISING AWARENESS
OLDER.
WE KNOW THAT PNEUMOCOCCAL KILLS
ONE IN EVERY FOUR TO FIVE PEOPLE
OVER 65 WHO CONTRACT IT OR 95%
OF THE COMPLICATIONS THAT OCCUR.
IN 2012 CDC INDICATED 20% OF
ADULTS AT HIGH RISK FOR
PNEUMONIA HAD RECEIVED THE
VACCINE.
IT HAS CONSEQUENCES INCLUDING
MORE THAN 600,000 ANNUAL
HOSPITALIZATIONS AND DIRECT LOSS
OF $14 MILLION A YEAR.
WE CALL FOR A GREATER PUBLIC AND
PRIVATE EFFORTS TO RAISE
AWARENESS FOR IMMUNIZATIONS.
OUR PROGRAM SERVED HUNDREDS OF
THOUSANDS OF SENIORS EVERY DAY.
ONE CASE OF FLU AT OUR CENTERS
CAN AND DOES SPREAD AND COULD
HAVE BEEN PREVENTED.
LET US AND OTHER NATIONAL AGING
ORGANIZATIONS WORK WITH THIS
COMMITTEE TO INCREASE AWARENESS
FOR AT RISK OLDER ADULTS.
THANK YOU VERY MUCH.
THANK YOU VERY MUCH.
>>> VIRGINIA LAD, AMERICAN
AUTOIMMUNE RELATED DISEASES
ASSOCIATION.
I HAVE NO CONFLICTS.
AUTOIMMUNE DISEASES ACCORDING TO
NIH EFFECT UP TO 24 MILLION
AMERICANS.
THAT IS LOOKING AT 26 OF THE
MORE THAN 100 AUTOIMMUNE
DISEASES.
MOST AUTOIMMUNE DISEASES OTHER
THAN ENDOCRINE ONES ARE TREATED
WITH IMMUNO SUPPRESSANTS WHICH
INCLUDE PREDNISONE.
IN THE LAST DECADE THE TARGETED
BIOLOGICS HAVE BEEN ADDED AND
HAS BEEN VERY EFFECTIVE.
THESE THERAPIES DO SUPPRESS THE
IMMUNE SYSTEM SIGNIFICANTLY.
THE AUTOIMMUNE DISEASES THAT ARE
CAUSED BY DISREGULATION OF THE
IMMUNE SYSTEM WHICH HAVE A
HYPERRESPONSE TO YOURSELF.
SO THE ONLY TREATMENT IS TO DOWN
REGULATE THAT IMMUNE SYSTEM FOR
THE DISEASE.
SO THIS MAKES THE PATIENT VERY
VULNERABLE TO INFECTIONS AND
PNEUMONIA PARTICULARLY WHICH
MANY ARE HOSPITALIZED AS A
RESULT OF THAT EACH YEAR.
THE AVERAGE AGE OR THE AVERAGE
PERSON THAT WOULD GET AN
AUTOIMMUNE DISEASE, 75% ARE
WOMEN AND IT USUALLY OCCURS
BEFORE THE AGE OF 50.
SO THE CHILD BEARING YEARS.
IT IS A YOUNGER POPULATION.
SO WE WOULD LIKE TO SUGGEST THAT
YOU INCREASE THE NUMBERS OF
PEOPLE VACCINATED TO PROTECT
THESE PEOPLE EVEN THOUGH I
UNDERSTAND THE RECOMMENDATION
FOR IMMUNE COMPROMISED PEOPLE IS
THERE.
WHEN YOU LOOK AT THE PERCENTAGE
OF OLDER FOLKS WHO ARE NOT
VACCINATED AND THEN YOU CONSIDER
THE NUMBERS, REALLY MILLIONS OF
YOUNG PEOPLE WITH AUTOIMMUNE
DISEASE YOU WILL SEE THAT VERY
FEW OF THEM -- NOT VERY FEW, BUT
THE PERCENTAGE OF THEM THAT WILL
NOT BE VACCINATED.
SO THE HERD EFFECTS IS VERY
IMPORTANT FOR THIS POPULATION
AND INCREASING OR LOWERING THE
AGE WILL INCREASE THE HERD
EFFECTS FASTER UNTIL 2019.
THANK YOU VERY MUCH.
>> THANK YOU VERY MUCH.
FRANK SMILY.
>> I DON'T NEED THIS THING
PROBABLY.
I'M FRANKIE MILLIE.
I'M THE MOTHER OF AN ONLY CHILD
WHO DIED OF A PNEUMOCOCCAL
DISEASE.
I USUALLY DON'T DO THIS BUT I
MADE A FEW POINTS BECAUSE I
DIDN'T WANT TO FORGET ANYTHING.
I WANT TO THANK THE VOTING
COMMITTEE, WORKING GROUP AND
EVERYBODY HERE WHO HAS SPENT SO
MANY HOURS OF THEIR LIFE
DEDICATED TO MAKING SURE WE ARE
ALL PROTECTED AGAINST VACCINE
PREVENTABLE DISEASES.
MANY OF US OWE YOU OUR LIVES AND
LIVES OF CHILDREN AND FAMILY
MEMBERS.
AGAIN, I WANT TO SPEAK TO THE
PNEUMOCOCCAL VACCINE.
AS THE COMMITTEE MOVES FORWARD I
AM KIND OF DISAPPOINTED YOU
DIDN'T JUST VOTE AND PUT THIS TO
BED.
WITH THAT BEING SAID I WANT TO
SAY AS YOU MOVE FORWARD AND
STILL DISCUSSING THIS THAT YOU
NEED TO BE REMINDED THAT IN MY
WORLD OF DEALING WITH PARENTS,
WHICH I DEAL WITH MANY EVERY DAY
ON BOTH SIDES OF THE FENCE, SOME
WITH THEIR LITTLE SPACE CADET
THEORIES THAT YOU GUYS ALL CAME
FROM A SPACESHIP.
I WANT YOU TO KNOW THAT I THINK
WE HAVE SEVERAL RISKS BY
DELETING THIS DOSAGE.
THE FIRST ONE BEING THAT MOST
PARENTS IF YOU TOLD THEM THEY
NEED FOUR DOSES OF SOMETHING
THEY MAY GET THREE.
IF YOU NEED THREE DOSES OF
PNEUMOCOCCAL VACCINE THEY ONLY
GET TWO.
ANOTHER IS YOU NEED TO BE
REMINDED I SPENT YEARS OF MY
LIFE WORKING, VOLUNTEERING AND
MAKING SURE THAT REQUIREMENTS
AND RULES ARE MADE AND PASSED
STATE TO STATE REQUIRING DAYCARE
ENTRY AND MIDDLE SCHOOL ENTRY
AND COLLEGE ENTRY LAWS REGARDING
MENINGITIS.
MY FEAR IS THAT A LOT OF THESE
LAWS AND RULES ACTUALLY SPELL
OUT INDICATION AND DOSAGE -- IF
WE GO BACK AND CHANGE THE DOSAGE
RECOMMENDATION WE WILL HAVE TO
GO BACK AND ADJUST A LOT OF
THOSE RULES AND LAWS.
I'M GOING TO TELL YOU RIGHT NOW
WE ARE GOING TO LOSE THOSE LAWS
AND RULES BECAUSE THE
ANTI-VACCINE MOVEMENT IS STRONG,
STRONGER THAN EVER.
THEY ARE GOING TO BE FIGHTING US
ON EVERY TURN.
I HAVE SPENT 13 YEARS OF MY
LIFE.
RYAN'S 16th ANNIVERSARY OF HIS
DEATH WAS TUESDAY.
I SPENT 13 OR MORE OF THOSE
YEARS SINCE HIS DEATH FIGHTING
TO MAKE SURE OUR KIDS ARE
VACCINATED.
I'M AFRAID WHEN YOU START
TALKING ABOUT CHANGING RULES WE
RISK LOSING THE LAWS THAT WE
ALREADY HAVE IN PLACE AND THE
REQUIREMENTS.
THIRDLY, I THINK WE SEND MIXED
MESSAGES WHEN WE START CHANGING
DOSAGE AFTER WE KNOW THEY WORK
AND HAVE PROVEN TO WORK AND
SEEING DECLINES IN DISEASE.
I THINK WE ARE SENDING MIXED
MESSAGES TO PARENTS WHO ARE
RESISTANT TO VIRUS.
THEY WILL SAY WE DIDN'T NEED ALL
OF THESE TO BEGIN WITH.
SO FINALLY AS WE SAY IN TEXAS
ONCE MORE IF IT AIN'T BROKE
DON'T FIX IT.
AND SOME OF THESE JUST AREN'T
BROKE.
YOU GUYS DO A GOOD JOB AND I
KNOW AT THE END OF THE DAY WHEN
THIS IS OVER WITH YOU ARE GOING
TO VOTE TO KEEP IT.
I THINK IT IS THE RIGHT THING TO
DO.
ONE LAST THING, GREGORY THAT WAS
WITH ME A FEW MONTHS AGO IN
FEBRUARY WITH HIS PARENTS AND
MOTHER CAME UP AND SPOKE.
GREG IS IN THE HOSPITAL HAVING
SURGERY TO TRY TO STOP SEIZURES
AGAIN AND ALSO SOME
RECONSTRUCTIVE SURGERY ON SOME
OF HIS BONES AND HEALTH.
OUR KIDS THAT FIGHT DISEASE
DON'T COME HOME FROM THE
HOSPITAL AND IT IS OVER WITH.
THEY EITHER DIE OR COME BACK
FROM THE HOSPITAL AND FACE LIFE
FULL OF SURGERY AND TORMENT AND
TORTURE AND RIDICULE AND HURT
AND DISAPPOINTMENT.
DON'T START CHANGING RULES THAT
YOU HAVE ALREADY MADE AND
RECOMMENDATIONS WHEN THEY ARE
FOR THE RIGHT THING AND HELP TO
SAVE LIVES.
THANKS AGAIN.
THANK YOU.
I THINK IN THE INTEREST OF TIME
TO MOVE ALONG TO
THE UPDATE.
IF THERE IS A PUBLIC COMMENT AND
YOU ARE NOT REGISTERED PLEASE
REGISTER.
I THINK WE NEED TO
THE MEASLES.
>> AS YOU ARE COMING UP, I THINK
WE DO NEED TO GET GUIDANCE FOR
THE WORK GROUP AND WHERE WE ARE
HEADING WITH THIS.
IF WE CAN JUST TAKE A COUPLE OF
MINUTES AND TRY TO PROVIDE YOU.
AROUND THE TABLE, WE HAVE HEARD
A NUMBER POTENTIAL
SUGGESTIONS, FOR EXAMPLE, THE
TWO THAT WERE -- THE OPTIONS
OFFERED IN TERMS OF ADDING IN
PCV 13 AT AGE 65 AND SOMEHOW
SEQUENCING THAT WITH PPSV 23.
THE OTHER OPTION IS REPLACING
PPSV 23 WITH 13.
ANOTHER OPTION BE LOOKING AT
ALTERNATIVE AGES, FOR EXAMPLE,
AGE 60 IN CONJUNCTION WITH
CURRENT RECOMMENDATIONS FOR
OTHER VACCINE AT THAT AGE.
ARE THERE OTHER COMMENTS FROM
AROUND THE TABLE?
A VOTE BEFORE THE OCTOBER THECF
MEETING AND WHETHER THAT SHOULD
BE PLANNED FOR OR NOT.
I THINK THAT SINCE THIS IS A
PUBLIC MEETING I WANTED TO MAKE
SURE THAT THAT CONVERSATION
HAPPENS SO THATNPUT THAT
THE WORKING GROUP WILL GET CAN
HELP THEM DO WHAT THEY NEED TO
DO.
IF THIS IS AIMED FOR A VOTE
BEFORE WE RECONVENE IN OCTOBER.
>> IF I COULD JUST CLARIFY THE
IDEA OF HAVING AN EXTRA MEETING
TO DISCUSS THIS.
THE ADVANTAGE OF DOING THAT AND
POTENTIALLY MAKING A DECISION IN
THAT TIMEFRAME WOULD BE TO TRY
TO INFLUENCE ADVANCE OF THIS
YEAR'S INFLUENZA SEASON?
>> IF THE COMMITTEE IS READY TO
VOTE SOMETIME BEFORE OCTOBER
THEN CLINICIANSIC
SEEKING VACCINATIONS THIS FALL
WOULD KNOW WHAT VACCINE THEY
OUGHT TO BE SEEKING OR THEY
WOULD HAVE HEARD WHERE ACIP IS
GOING WITH THIS FORMALLY.
THERE IS A LOT OF VACCINATION
THAT HAPPENS IN SEPTEMBER AND
OCTOBER.
ON THAT POINT WE HEARD A LOT
OF CONCERNS FROM OUR PEDIATRIC
COLLEAGUES ABOUT THE SHORT TIME
INTERVAL BETWEEN A NEW
RECOMMENDATION AND THE ABILITY
OF PROVIDERS TO STOP THE VACCINE
THAT WOULD BE RECOMMENDED.
HOW MUCH OF A CONCERN WOULD THAT
BE IN THIS CONTEXT IF ACIP MADE
A RECOMMENDATION PRIOR TO THE
OCTOBER MEETING LATE SUMMER AND
EARLY FALL AN ATTEMPT TO
INFLUENCE IMMUNIZATION PRACTICES
THAT SAME FALL?
NATIONAL FOUNDATION FOR
INFECTIOUS DISEASES.
I DON'T HAVE AN ANSWER TO THIS
CONUNDRUM.
I WOULD LIKE TO TALK TO THE
ISSUE OF DIFFICULTY OF
TRANSLATING THE BEST EPID
EPIDEMIOLOGY SCIENCE.
THE PNEUMOCOCCAL RECOMMENDATIONS
WE HAVE ARE SINGLE MOST COMPLEX
RECOMMENDATIONS FOR ANY VACCINE
FOR ANY AGE GROUP AND CONSIDER
THEY ARE DIRECTED AT HEALTH CARE
PROVIDERS WHO ARE REMEMBER
YESTERDAY AFTERNOON'S
CONVERSATION, THE LEAST
EFFECTIVE IMMUNIZERS.
I COULD GIVE ANECDOTES OF LOCAL
ATTEMPTS TO TRANSLATE THE IMMUNO
COMPROMISED INTO PRACTICAL
EFFECT AND HAVE RUN INTO SERIOUS
DIFFICULTY.
HERE I ECHO TOMORROW'S COMMENTS.
SO AS WE APPROACH THIS
PHILOSOPHICALLY SEEKING
PERFECTION IS OFTEN THE CURRENT
ENEMY OF THE CURRENT GOOD.
YOU CAN BUILD A BEAUTIFUL
AIRPLANE BUT IF IT WON'T FLY IT
WON'T GET IT THERE.
AND RECALL PROVIDERS DON'T
RESPOND RAPIDLY TO
RECOMMENDATIONS.
IT TAKES CONSIDERABLE TIME TO
RESPOND.
I DON'T KNOW HOW WE ARE GOING TO
DO THIS BUT I URGE US TO
CONSIDER CLARIFYING AND
SIMPLIFYING THE WHOLE ARRAY OF
PNEUMOCOCCAL VACCINE
RECOMMENDATIONS AS WE GO FORWARD
IN AN ATTEMPT TO MAKE THEM WORK
MOST EFFECTIVELY FOR THE MOST
PEOPLE.
IN ADDITION TO THE PRACTIISS
PRACTICAL ISSUES FOR INSURANCE
COVERAGE.
THIS HAS IMPLICATIONS FOR THE
AGE THAT WE CHOOSE.
IF IT IS AGE 65 AND OVER CAN OUR
CMS LIAISON CLARIFY HOW QUICKLY
IT WILL COVER?
MEDICARE CURRENTLY COVERS PCV
13.
THE ISSUE IS CURRENTLY THERE IS
ONE VACCINE ADMINISTERED UNDER
MEDICARE.
SO WE HAVE WORKED WITH PCV AND
ARE LOOKING INTO THE ISSUE.
BUT JUST REMEMBER OFTEN MEDICARE
DOES N RECOMMENDATIONS.
IT IS A STATUTORY REQUIREMENT
THAT MEDICARE PROVIDE THE ONE
PNEUMOCOCCAL VACCINE.
THERE ARE ISSUES AND WE ARE
WORKING WITH CDC ON THE ISSUES.
AND THEN THE PRIVATE INSURER
ISSUES.
SO JUST CLARIFYING THAT BOTH THE
POLYSACCHARIDE AND THE CONJUGATE
ARE INCLUDED IN PART
B'S COVERAGE RIGHT NOW.
THE ISSUE IS IT ONE DOSE AT
65.
AND SO FOR THE WELCOME TO
MEDICARE POPULATION THAT IS
TYPICALLY OFFERED A PNEUMOCOCCAL
VACCINE THERE WOULDN'T BE A
DELAY DETERMINING WHICH ONE.
>> A FOLLOWUP TO THAT.
THE QUESTION, IF THE SUGGESTION
WAS TO DO A PCV 13 FOLLOWED BY
23 WOULD BOTH VACCINES BE
COVERED OR WOULD CMS ONLY PAY
FOR ONE?
>> THAT'S THE ISSUE THAT WE'RE
LOOKING INTO.
>> IF WE HAVE A VOTE BEFORE
OCTOBER I THINK THE PROCESS IS
VERY IMPORTANT BECAUSE THERE ARE
TWO WAYS TO DO IT.
YOU CAN SEND OUT A PROPOSAL AND
HAVE PEOPLE VOTE WITHOUT
DISCUSSION BY E-MAIL.
I WOULD NOT WANT THAT BECAUSE
THERE IS SO MUCH THAT COMES OUT
IN THE DISCUSSIONS AND SO MANY
POINTS THAT WE DON'T CONSIDER
NECESSARILY AHEAD OF TI
IT SHOULD BE A PHONE MEETING
WITH DISCUSSION.
>> THE RULES AND REGULATIONS
STATE ALL MEETINGS ARE OPEN TO
THE PUBLIC AND TRANSPARENT.
IT WOULD NOT BE PERMISSIBLE TO
HAVE VOTE BY E-MAIL.
WE CAN'T DO THAT.
IT IS NOT ALLOWED UNDER OUR
RULES AND REGULATIONS.
IF IT WERE A CALL IT WOULD BE
PUT ON THE FEDERAL REGISTRY 15
WORKING DAYS BEFORE THE CALL.
WE WOULD TRY TO NOTIFY EVERYBODY
ABOUT THAT IN OTHER WAYS
INCLUDING OUR WEBSITE.
IT WOULD HAVE PHONE LINES WHERE
THE PUBLIC COULD CALL IN AND
MAKE COMMENTS JUST LIKE WE DO AT
AN OPEN MEETING BUT A PHONE
CONVERSATION.
IT IS POSSIBLE TO DO THAT BUT WE
WILL FOLLOW ALL OF THE RULES AND
REGULATIONS.
>> KEVIN HAS A COMMENT AT THE
MICROPHONE.
>> THERE WAS A COMMENT BEFORE ON
STOCKING.
I WASN'T SURE IF IT WAS DIRECTED
TOWARDS THE MANUFACTURER.
IN THE EVENT THE COMMITTEE
DECIDES TO MAKE A DECISION EVEN
BEFORE OCTOBER WE HAVE VACCINE
AVAILABLE FOR PHYSICIANS THAT
IT.
WE HAVE A NUMBER OF PHYSICIANS
WHO STOCK PCV 13.
I THINK TO ADD TO THE POINT,
CLAIMS DATABASES SHOW 50% OF ALL
ADULT IMMUNIZATIONS IN THE
UNITED STATES TODAY OCCUR
BETWEEN SEPTEMBER AND DECEMBER.
SHE WAS RIGHT IN SAYING IF THERE
IS A POSSIBILITY TO ARE THE
DISCUSSION AND VOTE BEFORE THEN
YOU WOULD CATCH THE MAJORITY OF
THIS YEAR'S RESPIRATORY SEASON.
THANK YOU.
>> THE OTHER ISSUE IS THERE IS
AN ADVISORY COMMITTEE.
IF DR. FRIEDEN WOULD WANT A
MEETING HELD INTERMITTENTLY
BECAUSE OF PUBLIC HEALTH
EMERGENCY OR PUBLIC HEALTH NEED
THAT IS ENTIRELY POSSIBLE.
IT DOESN'T SEEM THERE IS ENOUGH
DATA DISTRIBUTED TO MAKE A VOTE
TODAY.
THERE IS A POSSIBILITY OF HAVING
A VOTE BEFORE THE NEXT MORNING
IF THAT IS NEEDED.
COMPLEX THE INFORMATION WAS TED
AND THAT THE COMMITTEE WASN'T
GOING TO BE ABLE TO VOTE TODAY.
THE HOPE WAS THAT THERE WOULD BE
ENOUGH INPUT TO HAVE THE WORKING
GROUP CONTINUE TO LOOK AT THIS
AND THAT A VIRTUAL MEETING, IF
YOU WANT ONE, CAN BE ARRANGED
FOLLOWING ALL OF THE LAWS.
THE ISSUE OF EXACTLY HOW
CONFUSING IT MIGHT BE OR HOW
LONG IT MIGHT TAKE TO GET
ACCEPTABLE UPTAKE TO THE NEXT
VOTE IS ONE THING BUT I DO THINK
THE IDEA THAT THERE WILL BE A
LOT OF COMMUNITY-ACQUIRED
PNEUMONIA THIS WINTER NO MATTER
WHAT THERE IS A LOT OF
COMMUNITY-ACQUIRED PNEUMONIA
THIS WINTER SHOULD WE BE DOING
ANYTHING TO MAKE SURE THAT
CONSUMERS AND CLINICIANS AND
PHARMACISTS AND PUBLIC HEALTH
KNOWS WHERE YOU ARE GOING ON
THIS BECAUSE THE VACCINE IS
ALREADY LICENSED AND COVERED BY
MEDICARE ANYWAY.
>> A FOLLOWUP WITH RESPECT TO
THE COST ISSUES.
THE NICE THING ABOUT LOOKING AT
AGE 60 IS THAT SHIFTS SOME OF
THE BURDEN ON AFFORDABLE CARE
ACT COMPLIANCE PROGRAMS THAT
AVOID A LOT OF THE ISSUES WE
FACE WITH MEDICARE AND THESE
CONCERNS.
AT LEAST IT WOULD ALLOW SOME
PART OF THE AGE GROUP TO TEN
POTENTIALLY TAKE A LOOK AT IT.
>> JUST WANTED TO CLARIFY THAT
I'M A LITTLE CONFUSED ABOUT
WHETHER THE VACCINE -- WELL, I
GUESS, WHAT THE MEDICARE
COVERAGE SITUATION IS.
AND INDIC VACCINE IS
COVERED AND IF 13S USED
THAT MEANS THE 23 VALENT WOULD
NOT BE COVERED?
MEDICARE CURRENTLY PAYS FOR
BOTH.
THE ISSUE IS A PERSON IS
ELIGIBLE FOR ONE VACCINE.
IF THEY GOT THE 13 VALENT
THEY WOULD NO LONGER BE ELIGIBLE
FOR THE 23 VALENT.
>> YES.
AND POTENTIALLY.
THE STANDARD RULE IS YES.
THERE MAY BE SITUATIONS WHERE IT
IS COVERED.
WE ARE WORKING THROUGH THAT
RIGHT NOW.
WHAT IS YOUR TIMELINE?
IT WOULD BE IMPORTANT FOR THE
WORKING GROUP AND ACIP TO KNOW
WHETHER BOTH WOULD BE COVERED
FOR THEIR DECISION MAKING
PROCESS.
WHAT IS YOUR TIMELINE FOR
RESOLVING IT?
I AM NOT IN A POSITION TO
GIVE A TIMELINE RIGHT NOW.
THIS IS -- AGAIN, MEDICARE
COVERAGE IS BASED ON A STATUTORY
PROVISION, STATUTORY
REQUIREMENT.
SO WE JUST STARTED TO EXPLORE
THE WITH THIS.
SO RIGHT NOW WE AREN'T IN A
POSITION TO GIVE A TIMELINE.
JUST TO FOLLOWUP, I BELIEVE
THAT WITHOUT KNOWING THAT
INFORMATION WHAT WE MIGHT
ACTUALLY DO IS SHIFT FROM THE 23
VALENT TO THE 13 WHICH WAS NOT A
DESIRABLE ALTERNATIVE.
I THINK THAT IS CRUCIAL TO KNOW
BEFORE WE DECIDE TO HAVE A VOTE.
AMERICAN COLLEGE OF
PHYSICIANS.
AS WE HAVE HEARD TODAY
PNEUMOCOCCAL VACCINATION IS VERY
IMPORTANT AND LIFE SAVING AND
VERY CONFUSING AND CURRENTLY
VERY DYSFUNCTIONAL IN
IMPLEMENTING THE APPROPRIATE
VACCINATION PROGRAM.
BECAUSE THE RECOMMENDATIONS ARE
SO COMPLICATED AND CONFUSING IF
WE MOVE FORWARD WITH THIS
CLARITY IS DEFINITELY NEEDED.
WE NEED TO SIMPLIFY IT AS MUCH
AS POSSIBLE.
BUT YOU ARE TALKING ABOUT GIVING
THIS TO 65 YEAR OLDS AND ABOVE.
IF WE DON'T HAVE MEDICARE
COVERAGE WE'RE SUNK BEFORE WE
BEGIN.
THIS IS NOT A $20 VACCINE.
THIS IS NOT A $23 VACCINE.
I WOULD LOVE FOR THE
MANUFACTURERS TO GET UP TO THE
MIC AND TELL US WHAT THEY'RE
SELLING IT TO PRACTITIONERS FOR.
PATIENTS, PHYSICIANS CAN'T EAT
THIS.
IT HAS TO BE COVERED.
BIG BARRIER.
WE NEED ALL OF YOUR HELP IN
HELPING US MOVE THINGS QUICKLY.
WE HAVE TIME IS OF THE ESSENCE.
WE HAVE A GREAT VACCINATION
OPPORTUNITY TO COMBINE WITH FLU
VACCINATIO
VACCINATION.
IT WILL NOT BE SUCCESSFUL IF
MEDICARE DOESN'T BUY IN AND GIVE
US COVERAGE.
I IS IMPLIED THIS IS
A VERY COMPLICATED ISSUE AND IT
IS HARD TO GET TO ANY RESOLUTION
IN VIRTUALLY NO TIMEHERE.
I WOULD SUGGEST THAT WE CONSIDER
HAVING A THREE TO FOUR HOUR
PERIOD DESIGNATED SOMETIME IN
AUGUST THAT WE CAN REVISIT A LOT
OF THESE ISSUES AND TAKE OUR
TIME AND NOT FEEL RUSHED WITH
THAT.
TO DO SO I THINK WE CAN DO THAT
VIA WEB CONFERENCE OR
TELECONFERENCE.
I WOULD ENDORSE THAT IDEA RIGHT
NOW BECAUSE LITERALLY I THINK WE
COULD KEEP HAVING PEOPLE DISCUSS
THIS FOR THE NEXT TWO HOURS HERE
AND STILL NOT COME TO ANY
RESOLUTION.
I THINK WE REALLY NEED A WELL
THOUGHT OUT PERIOD OF TIME WHERE
WE LOOK AT SOME OF THE OPTIONS.
WE ALSO NEED TO HAVE A
RELATIVELY FORMAL GRADE
PRESENTATION PARTS OF WHICH HAVE
BEEN DONE BUT TO HAVE THAT LAID
OUT AGAIN FOR US FOR
DELIBERATION IF A DECISION IS
GOING TO BE MADE.
JUST TO SUMMARIZE, WHAT I'M
HEARING IS THAT PEOPLE ARE
INTERESTED IN MOVING THE
TIMELINE ON THIS DECISION
FORWARD IF POSSIBLE AND
THEREFORE HAVING AN ADDITIONAL
MEETING.
I THINK THE WORK GROUP NEEDS TO
THE ISSUES RAISED TODAY ABOUT
FEASIBILITY OF IMPLEMENTATION
AND ALSO ABOUT THE POINT THAT
WAS RAISED WHICH IS THE QUESTION
OF SIMPLICITY AND IF THERE IS
SOMETHING THAT COULD BE AMORE
R
RADICAL SOLUTION THAT WE DIDN'T
THINK OF.
WE HAD DIFFICULTY THINKING OF
ANY WAY TO SIMPLIFY IT.
IT IS JUST COMPLEX.
I THINK THE WORK GROUP WILL
QUICKLY RECONVENE ANTHE ISSUE A
DETERMINE WHETHER OR NOT WE CAN
COME FORWARD TO THE COMMITTEE BY
AUGUST WITH A STRONG
RECOMMENDATION FOR THE VACCINE.
AND WE CLEARLY NOTIFY
EVERYONE THROUGH THE FEDERAL
REGISTRY IF THERE IS A MEETING
TO BE HELD.
WE WILL DO EVERYTHING WE CAN TO
ENSURE THAT THE PUBLIC IS
INVOLVED IN THIS MEETING.
>> WE'LL GIVE YOU THE LAST WORD.
AS A MEMBER OF THE WORKING
GROUP I PROBABLY SHOULD KNOW
THIS.
WE WILL HAVE TO DEAL WITH THE
QUESTION OF WHAT TO RECOMMEND OF
THE CONJUGATE VACCINE IN PEOPLE
WHO HAVE RECEIVED THE DOSE OF
POLYSACCHARIDE?
THAT IS THE PROBLEM.
WHEN I TRY TO THINK ABOUT
SIMPLICITY I AM DUMBFOUNDED
BECAUSE I DON'T THINK THERE IS A
WAY TO MAKE IT SIMPLE.
I THINK WE SHOULD ALL GIVE IT
ADDITIONAL THOUGHT AND SEE IF
THERE IS POSSIBILITY.
IF THERE IS NO HOPE OF
SIMPLIFYING THERE IS MOW POINT
IN HOLDING BACK EITHER.
I THINK THAT IS WHAT WE HAVE TO
WEIGH.
>> I THINK THE OTHER THING THAT
THE WORKING GROUP MIGHT CONSIDER
IS A NARROW VOTE THAT COULD BE
IMPLEMENTED QUICKLY ADDRESSING
MUCH OF THE REST OF IT LATER.
SO FOR THE PERSONS UNDER 65 OR
THOSE WHO THINK THEY DIDN'T HAVE
A DOSE AND THEN TAKE ALL ISSUES
AT A LATER
IF YOU CAN DO EVERYTHING AT ONCE
I THINK THE CLINICIANS WOULD
APPRECIATE IT.
>> I AGREE WITH THAT EXCEPT THAT
I THINK WE REALLY NEED AN ANSWER
ABOUT THE COVERAGE BECAUSE IF
WHAT WE ARE TALKING ABOUT IS ONE
VACCINE VERSUS THE OTHER THAT'S
A VERY DIFFERENT DECISION.
>> I'M NOT SURE HOW WE CAN GO
FORWARD WITHOUT KNOWING WHETHER
BOTH VACCINES WILL BE COVERED. N
FOR ONE OR THE OTHER AND
DISQUALIFIED FROM RECEIVING THE
COMPLIMENTARY VACCINE THAT THEY
NEED IS COUNTER PRODUCTIVE.
I THINK IT IS INTIMATELY TIED TO
WHETHER OR NOT THE MEDICARE
ISSUE WILL BE RESOLVED.
I DON'T SEE THE POINT GOING
FORWARD WITHOUT THAT BECAUSE
THEN YOU DISQUALIFY PATIENTS
FROM RECEIVING ONE OF THE TWO
VACCINES.
JUST A SIDE POINT I'M TRYING
FRANTICLY TO CONFIRM THIS
RESEARCH BUT IT IS MY
RECOLLECTION THAT UNDER THE ACA
REQUIREMENTS I BELIEVE PRIVATE
PLANS ARE NOT REQUIRED TO COVER
THE NEW VACCIEW VACCINATIONS UN
NEXT PLAN YEAR.
THAT COULD BE AT THE END OF THE
NEXT VACCINATION SEASON OR AFTER
THAT.
>> JUST A CLARIFICATION.
JUST FOR EVERYBODY TO KNOW THAT
WITH THE DISCUSSION RUNNING LONG
HERE THE PERTUSSIS DISCUSSION
THAT WE ARE GOING TO DEFER TO
THE NEXT MEETING.
AND WE ACTUALLY GIVE OUR
COMPLIMENTS TO WORKING GROUP FOR
FLEXIBILITY.
JUST SO WE HAVE THAT IN TERMS OF
LEEWAY WITH OUR DISCUSSION HERE.
BUT JUST TO CLARIFY IF A
DECISION WERE MADE IN AUGUST OR
OCTOBER FOR SOMEONE UNDER THE
AGE OFN WOULD THAT BE
IMPLEMENTED UNDER ACA FOR
INSURERS UNDER ACA?
MY UNDERSTANDING IS SIMILAR
TO WHAT WAS STATED THAT IT COULD
BE DEFERRED UP TO THE NEXT PLAN
YEAR.
HOWEVER, MANY PLANS DO IMPLEMENT
THIS UPON THE RECOMMENDATION.
SO IT WILL BE SOMEWHAT VARIABLE
IN THE MARKET PLACE.
THEY ACTUALLY HAVE 12 MONTHS
AFTER PUBLICATION IN THE MMWR,
THE NEXT PLAN YEAR COMING UP FOR
THAT.
IT CAN BE LONGER THAN 12 MONTHS
AFTER PUBLICATION.
YOU MIGHT BE TALKING A COUPLE OF
SEASONS.
DOESN'T MEAN MANY PLANS WOULDN'T
DO IT FIRST.
WITH ALL OF THAT DISCUSSION
THAT DOES GIVE YOUR WORK GROUP
SOME THINGS TO THINK ABOUT.
>> I DON'T THINK WE LACK FOR
THINGS TO THINK ABOUT.
BUT WE ARE VERY APPRECIATIVE TO
THE INPUT OF THE COMMITTEE AND
WE WILL BE GETTING BACK TO YOU
VERY SOON.
>> AND WITH THAT I THINK THE
SECRETARY WILL EXPLORE THE
POSSIBILITY AND THE AVAILABILITY
OF PEOPLE FOR POTENTIALLY A
CONFERENCE IN AUGUST?
OKAY.
THANK YOU.
MY APOLOGIES ALSO TO MR. GOODSON
AND MR. WALLACE.
IF WE CAN MOVE ON.
WE PLAN TO TAKE A SHORT BREAK
AFTER THE MEASLES PRESENTATION.
THANK YOU.
THANKS VERY MUCH.
GOOD MORNING.
AND SOME PEOPLE -- I AM FROM THE
GLOBAL IMMUNIZATION DIVISION
HERE AT CDC.
IT IS MY PLEASURE TO PROVIDE YOU
WITH THE MEASLES UPDATE.
I WOULD LIKE TO ACKNOWLEDGE
CONTRIBUTIONS OF THE
PRESENTATION FROM PARTNERS FROM
THE INITIATIVE LISTED ON THE
BOTTOM OF THE SLIDE.
SO THIS IS AN OVERVIEW OF MY
PRESENTATION TODAY FOLLOWED BY
DOMESTIC MEASLES UPDATE GIVEN BY
DR. GREG WALLACE.
WE WOULD LIKE TO TRY TO LEAVE
TIME FOR QUESTIONS AND COMMENTS.
I WILL TALK ABOUT THE GLOBAL
VACCINE ACTION PLAN OTHERWISE
CALLED GVAP, MEASLES AND RUBELLA
STRATEGIC PLAN AND VISION AND
PROGRESS TOWARDS MEASLES
ELIMINATION.
MOST OF YOU ARE PROBABLY
FAMILIAR WITH THE GVAP WHICH IS
THE KEY GLOBAL DOCUMENT WHICH
SERVES AS GUIDE FOR GLOBAL
IMMUNIZATION EFFORTS.
IT WAS DEVELOPED LARGELY FUNDED
BY THE BILL AND MELINDA GATES
FOUNDATION.
THE GVAP WAS APPROVED IN 2012.
ANOTHER KEY DOCUMENT IS THE
GLOBAL MEASLES AND RUBELLA
STRATEGIC PLAN DEVELOPED BY THE
MEASLES AND RUBELLA INITIATIVE
ESTABLISHED IN 2001 BY FIVE
PARTNERS, AMERICAN RED CROSS,
CDC, U.N. FOUNDATION, UNICEF.
THE STRATEGIC PLAN WAS MAINTAIN
WORLD WITHOUT MEASLES, RUBELLA
AND CONGENITAL RUBELLA SYNDROME.
AT THE GLOBAL LEVEL THERE ARE
THREE TARGETS TO BE ACHIEVED BY
2015 THAT HAVE BEEN SET.
COVERAGE WAS FIRST DOSE.
OF AT LEAST 90% AT THE NATIONAL
LEVEL.
REPORTED INCIDENTS AND MORTALITY
REDUCTION OF 95% COMPARED TO
2000 LEVEL.
THE GVAP SETS A GOAL FOR
ELIMINATION IN FIVE OF THE SIX
REGIONS OF THE WORLD BY 2020.
AND NOW SINCE SEPTEMBER OF LAST
YEAR WHEN THE SOUTHEAST ASIA
REGION ADOPTED AN ELIMINATION
GOAL FOR MEASLES WE HAVE ALL SIX
REGIONS OF THE WORLD WITH A DATE
FOR MEASLES ELIMINATION SET
LISTED HERE ON THE SLIDE.
YOU CAN SEE THE DATES FOR EACH
OF THE REGIONS.
IN ADDITION TWO OF THE SIX
REGIONS HAVE ESTABLISHED RUBELLA
ELIMINATION TARGETS.
SO WE WILL REVIEW A LITTLE BIT
ABOUT HOW FAR WECOME.
SO AS MANY OF YOU ARE AWARE THIS
YEAR MARKS THE 40th ANNIVERSARY
OF THE PROGRAM. E.P.I. WAS EST
GLOBELY IN 1974.
IT IS WORTH LOOKING BACK AT
IMPACT OF MEASLES VACCINATION.
WE HAVE A
ROXIMATELY 4
MILLION CASES IN 1980 TO A
LITTLE OVER 200,000 IN 2012.
AND SINCE 1985 THERE HAS BEEN AN
IMPRESSIVE 90% REDUCTION IN
ESTIMATED MEASLES DEATHS WORLD
WIDE.
AS PREVIOUSLY MENTIONED IN
STRATEGIC PLAN WE MONITOR
PROGRESS SINCE 2000.
DURING 2000 TO 2012 THERE IS A
77% DECREASE IN INCIDENTS WITH
78% DECREASE IN DEATHS.
ALTHOUGH WE ARE SHORT OF THE
2015 TARGET OF 95% REDUCTION WE
STILL HAVE SEEN 13.8 MILLION
DEATHS AVERTED THROUGH MEASLES
VACCINATIONS THROUGH 2000.
THIS SLIDE SHOWS GREAT PUBLIC
HEALTH SUCCESS.
IT IS BOTH THOSE VIRUSES,
ENDEMIC VIRUSES ELIMINATED IN
THE WESTERN HEMISPHERE.
TODAY THE REGION OF AMERICAS
CONTINUES TO BE THE MODEL FOR
MEASLES ELIMINATION.
VACCINATION STRATEGIES
SUCCESSFULLY STOPPED ENDEMIC
MEASLES VIRUSND RUBELLA IN 2009
THIS CHART SHOWS THE SECULAR
TREND IN COVERAGE.
GLOBALLY COVERAGE LEVELLED OFF
AT 84%.
THREE REGIONS STILL HAVE
COVERAGE LESS THAN 90%, AFRICAN
REGION, SOUTHEAST ASIA REGION
AND MEDITERRANEAN REGION.
REGION OF THE AMERICAS, EUROPEAN
REGION AND WESTERN PACIFIC
REGION HAVE SUSTAINED ABOVE 91%
OVER THE LAST EIGHT YEARS.
THE MAP ON THE RIGHT SHOWS
COVERAGE BY COUNTRY AND THOSE IN
PINK AND RED ARE COUNTRIES THAT
ARE BELOW 80%.
W.H.O. RECOMMENDS ALL CHILDREN
RECEIVE TWO DOSES OF MEASLES
VACCINE, GLOBAL COVERAGE,
REMAINS LOW AND WAS 56% IN 2012.
AND THIS WAS PRIMARILY DUE TO A
NUMBER OF COUNTRIES THAT HAVE
INDICATED ONUC ROUTINE SECOND
MAP ONN THE RIGHT.
THE NUMBER OF COUNTRIES WITH
ROUTINE IS INCREASING EACH YEAR
AND THERE WERE AN ADDITIONAL
FIVE PLANNED FOR 2014 THIS YEAR.
AND EACH YEL
THE SECOND DOSE.
AND IT
THE ROUTINE SECOND DOSE IN MANY
COUNTRIES CAN PROVIDE
IMPORT FOR E.P.I.
VACCINATIONS TO EXTEND BEYOND
THE FIRST YEAR OF LIFE.
IN ADDITION TO ROUTINE DELIVERY
OF MEASLES VACCINATIONS 33
COUNTRIES RELEASED CAMPAIGNS IN
2013.
IN THESE CAMPAIGNS NEARLY 200
MILLION CHILDREN WERE VACCINATE
ADDITION TO MEASLES MAINLY
RUBELLA AND POLIOVACCINES.
IN ADDITION TO VACCINATIONS
ANOTHER CRITICAL COMPONENT IS
IMPLEMENTATION OF CASE-BASED
SURVEILLANCE.
THE GLOBAL MEASLES AND RUBELLA
LABORATORY NETWORK WY
ESTABLISHED IN 2000 AND HAS
GROWN FROM 80 LABS 2
OVER 700 LABS TODAY.
OUR CDC LABORATORY HERE IN THE
DIVISION OF VIRAL DISEASES
SPECIALIZED
MEASLES AND RUBELLA LABORATORY
WITHIN THE LAB NET. NETWORK ESTD
STANDARDIZED TESTING PROCEDURES
AND MAINTAINS A STRONG QUALITY
ASSURANCE PROGRAM, ANNUAL
PROFICIENCY TESTING.
ALSO HAS ESTABLISHED GLOBAL
REFERENCE STREAMS AND
NOMENCLATURE UPDATED AND
PUBLISHED.
AND THE GLOBAL DATABASE FOR
COUNTRIES TO SUBMIT VIRUS
GENOTYPES.
SO THIS MAP SHOWS THE GLOBAL
DISTRIBUTION DETECTED.
DURING THIS PERIOD OF THE 24
KNOWN MEASLES VIRUS GENOTYPES
THERE WERE EIGHT DETECTED AND
SOME HAVE CLEARLY BEEN
ELIMINATED.
FROM THE SURVEILLANCE DATA WE
CAN SEE HERE REPORTED MEASLES
CASES BY MONTH FROM 2008 THROUGH
APRIL 2014 IN STACKED BARS BY
W.H.O. REGION.
IN 2014 YOU SEE THE WESTERN
PACIFIC REGION EXPERIENCING AN
INCREASE IN CASES LARGELY DUE TO
INCREASE IN REPORTED CASES IN
CHINA AND LARGE OUTBREAK IN THE
PHILIPPINES WHICH YOU WILL HEAR
A LITTLE MORE ABOUT IN THIS
PRESENTATION AND THE NEXT ONE.
SO THIS MAP SHOWS REPORTED
MEASLES INCIDENTS FOR 12-MONTH
PERIOD DURING 2013 AND 2014 AND
GIVES AN INDICATION OF COUNTRIES
EXPERIENCING A HIGH MEASLES
BURDEN, IN PARTICULAR THE DARK
RED COLOR INDICATES
WITH 50 OR MORE MEASLES.
AND THIS INCLUDES THE
PHILIPPINES WHICH IS OVER HERE
AND INDICATED WITH DARK RED
COLOR.
SO I DID INCLUDE ONE SLIDE HERE
ON THE PHILIPPINES OUTBREAK
SINCE THIS WILL COME UP AGAIN IN
THE NEXT PRESENTATION.
THE GRAPH HERE SHOWS THE NUMBER
OF CONFIRMED MEASLES CASES BY
MONTH FROM 2009 TO 2014.
THE RED PORTION OF THE BARS
INDICATE LAB CASES.
THE BLUE BAR IS CLINICILY
COMBATABLE CASES.
PRIOR TO 2013 PHILIPPINES
EXPERIENCED TWO LARGE OUTBREAKS
EACH WITH APPROXIMATELY 6,000
CASES.
HOWEVER, THE CURRENT OUTBREAK IS
MUCH LARGER AND IT STARTED IN
OCTOBER OF 2013.
IT PEAKED IN JANUARY OF 2014
WITH OVER 8,000 REPORTED CASES
IN THAT MONTH ALONE.
FINDINGS FROM THE OUTBREAK
INVESTIGATION THAT CDC
CONTRIBUTED TO AND COLLABORATED
WITH THE MINISTRY OF HEALTH AND
W.H.O. INDICATED THERE WERE MORE
THAN 26,000 SUSPECTED MEASLES
CASES INCLUDING 6,000 THAT WERE
LABORATORY CONFIRMED AND OVER
100 REPORTED MEASLES DEATHS.
42% OF THE CONFIRMED CASES WERE
IN THE METRO MANILA AREA AND
MAJORITY WERE AMONG CHILDREN
LESS THAN FIVE YEARS OF AGE WHO
WERE NOT VACCINATED OR UNKNOWN
VACCINATION STATUS.
SO I WOULD LIKE TO CONCLUDE BY
ACKNOWLEDGING ALL OF THE MEASLES
AND RUBELLA INITIATIVE PARTNERS
LISTED HERE AND HIGHLIGHT
IMPORTANCE AND GREAT
APPRECIATION OF THE U.S. SUPPORT
TO THESE GLOBAL EFFORTS.
THIS SUPPORT IS CRITICAL FOR
REDUCING MORBIDITY AND DEATH AND
LOWERING IMPORTATION PRESSURE
HERE AT HOME AND HELPING TO
MAINTAIN ELIMINATION IN THE
REGION OF THE AMERICAS.
GREG WILL PROVIDE AN UPDATE
THE DOMESTIC SITUATION.
THANKS.
>> THANK YOU.
THIS FIRST SLIDE IS JUST A SLIDE
THAT OUR LAB PUT TOGETHER
PREVIOUSLY.
AND IT SHOWS THAT THE OUTBREAK
IN THE PHILIPPINES INTO SEVERAL
OTHER COUNTRIES INCLUDING UNITED
STATES.
YOU CAN SEE MOST OF THE
IMPORTATIONS ARE GENOTYPES B 3
THERE IS ANOTHER CIRCULATING IN
A DIFFERENT REGION OF THE
PHILIPPINES IMPORTED INTO THE
UNITED STATES.
THIS IS A SNAPSHOT OF WHERE WE
HAVE GOTTEN MEASLES IMPORTATIONS
THIS YEAR.
AND SO WHAT IS IMPORTANT TO
REMEMBER FROM YEAR TO YEAR IS
THAT IMPORTATIONS ARE INFLUENCED
BY WHAT IS HAPPENING IN
NEIGHBORING COUNTRIES AND ALSO
TRAVEL PATTERNS.
WE TEND TO BE LESS SENSITIVE
BECAUSE OF TRAVEL PATTERNS TO
WHAT MAY BE HAPPENING IN AFRICA
WE ARE VERY SENSITIVE TO WHAT IS
HAPPENING IN EUROPE AND EUROPE
HAS BEEN THE DOMINANT
IMPORTATION SITE IN RECENT
YEARS, BUT THIS YEAR HAS
ACTUALLY BEEN VERY LOW.
BUT WHAT YOU DO SEE IS THAT
NEARLY HALF OF OUR IMPORTATIONS
THIS YEAR HAVE COME FROM THE
PHILIPPINES.
AND THIS IS A SLIDE THAT IS JUST
GOING TO SHOW THE NUMBER OF
REPORTED CASES BY MONTH FOR
DIFFERENT YEARS SINCE THE
BEGINNINGS OF THE ELIMINATION
AND DOCUMENTATION OF ELIMINATION
IN THE UNITED STATES.
IF YOU LOOK AT THE PERIOD OF
1997 TO 2001 THERE IS A RANGE OF
CASES OVER TIME BUT RELATIVELY
LOW.
AND THEN FROM THE PERIOD RIGHT
AFTER THE DOCUMENTATION OF
ELIMINATION THE RANGE WAS EVEN
LOWER THAN THAT.
YOU CAN SEE THAT MOSTLY WE WERE
NOT GETTING CASES AFTER ABOUT
JUNE.
AND THEN IN 2008 WE HAD A COUPLE
OUTBREAKS THAT CONSIDERED IT TO
LARGER CASES THAN WE HAD SEEN IN
RECENT YEARS.
AND THEN IN 2011 WE HAD OUR SORT
OF PREVIOUS RECORD YEAR WHICH
WAS INFLUENCED BY LOSS OF
TRANSMISSION WITHIN WESTERN
EUROPE WHICH LED TO MORE THAN
USUAL.
AND THEN WE HAD THE THREE YEARS
AFTER THAT.
SO 2012 WE GOT BACK TO WHAT WE
WOULD CONSIDER SORT OF OUR GOOD
OR NORMAL YEARS.
IN 2013 WE HAD THREE INDEPENDENT
OUTBREAKS THAT LED TO AN
INCREASE IN RELATIVE NUMBER OF
CASES WE HAD.
SO YOU CAN SEE WHILE IT IS
USUALLY MORE OF A SMOOTH LINE
YOU CAN SEE STEPS THAT INDICATE
THE THREE INDEPENDENT OUTBREAKS
THAT WERE UNRELATED THAT WE HAD
THAT YEAR.
AND THEN THIS YEAR YOU CAN SEE
WHERE THINGS STARTED EARLIER
THAN EVER BECAUSE OF THE
PHILIPPINES WHAT THEY WERE
EXPERIENCING WAS AN EARLIER
OUTBREAK AT LEAST IN SEASONAL
TERMS.
AND THEN WE HAD THE IMPORTATION
FROM PHILIPPINES THAT LED TO A
LARGE OUTBREAK THAT IS STILL ON
GOING.
SO JUST TO SUMMARIZE 48
IMPORTATIONS NEARLY HALF FROM
THE PHILIPPINES, AGAIN,
REFLECTING THEIR EPIDEMIOLOGY AS
WELL AS TRAVEL PATTERNS BETWEEN
OUR COUNTRIES.
IT IS IMPORTANT TO NOTE THAT THE
VAST MAJORITY OF CASES OF
IMPORTATION
IMPORTATIONS.
LOWER THAN USUAL REPORTED NUMBER
OF HOSPITALIZATIONS.
SOME OF THAT MAY HAVE TO DO WITH
THE CHARACTERISTICS OF THE
COMMUNITY SUFFERING THE LARGE
OUTBREAK THIS YEAR.
AGAIN, AMONG THOSE CASES OF U.S.
RESIDENTS MOST ARE UNVACCINATED.
MOST WITH UNKNOWN VACCINE STATUS
ARE ADULTS.
WE GET SOME CASES WHEN THIS MUCH
TRANSMISSION GOING ON.
AMONG NOT VACCINATED MOST HAVE
PERSONAL BELIEFS THAT LEAD THEM
TO NOT GET VACCINATED.
IT EFFECTS THOSE T-- IT AFFECTS
TOO YOUNG TO GET VACCINATED.
THIS IS A LIST OF 20 OR MORE
CASES.
IF YOU LOOK AT THE YEAR OF THE
OUTBREAK THEY ARE HAPPENING IN
RECENT YEARS.
OUR OUTBREAKS ARE LARGER THAN
PREVIOUSLY.
WHAT YOU MAY NOT SEE AT FIRST
GLANCE IS THAT IF YOU COMPARE O
OUTBTARTING IN OLDER
E'LL TALK ABOUT THA
BIT MORE. OT UNCOMMON TO HAVE A
OUTBREAK START IN AN OLDER AGE
GROUP AND THEN AS
THE HOUSEHOLD TROUPS
DROP AND YOU START AFFECTING
YOUNGER CHILDREN.
WE HAVE TWO OUTBREAKS CURRENTLY
ON GOING WITH THIS LARGE
OUTBREAK.
THIS IS
THAT HOPEFU TO BE
SLOWING DOWN AS A NEWOUTBREAK
YOU CAN SEE AN OUTBREAK THAT WE
HAD EARLIER THIS YEAR THAT ALSO
WAS A NUMBER OF CASES.
SO THIS IS JUST A QUICK E.P.I.
CURVE BY COUNTY OF THE OUTBREAK
CURRENTLY OCCURRING IN OHIO
WHERE WE HAD BASICALLY ALL THREE
OF THESE CASES HAD TRAVELLED TO
THE PHILIPPINES TO DO RELIEF
WORK TO HELP THEM REBUILD AFTER
THEIR HURRICANE.
BUT THEN IT GOT INTO THE
COMMUNITIES AND IT IS DOMINATED
BY ABOUT THREE COUNTIES.
BUT THESE ARE COMMUNITIES THAT
HAVE VERY COMPLEX MIXING
PATTERN.
WE THINK THAT THINGS ARE
STARTING TO SLOW DOWN BUT CASE
ASCERTAINMENT HAS BEEN AN ISSUE.
THERE HAS BEEN A LOT OF
VACCINATION GOING ON WITHIN THE
COMMUNITY.
JUST TO PUT EVERYTHING INTO
PERSPECTIVE PRIOR TO VACCINATION
IN THE UNITED STATES WE PROBABLY
HAD 3 MILLION OR 4 MILLION CASES
EVERY YEAR, TENS OF THOUSANDS OF
HOSPITALIZATIONS AND ABOUT 500
DEATHS EVERY YEAR.
AGAIN, TO PUT IT IN PERSPECTIVE,
PRIOR TO VACCINATION REPORTED
CASES WERE ABOUT 500,000.
YOU SEE A QUICK DROP WITH
VACCINATION PROGRAMS, SOME
CHALLENGES WITH SOME BLIPS.
A LOT OF THESE WERE ATTRIBUTABLE
WITH ONE DOSE OUTBREAKS IN
SCHOOL AGED KIDS.
LED TO SECOND DOSE
RECOMMENDATION THAT HAPPENED
JUST AS THE RESURGEANCE WAS
OCCURRING IN 1989 THROUGH '91
WHERE IT IS MOSTLY EFFECTING
INNER CITY KIDS WHO LACKED
ACCESS TO VACCINE WHICH HELPED
LEAD TO THE VSE PROGRAM WHICH
THE COMBINATION OF SECOND DOSE
RECOMMENDATION AND PROGRAM
REMOVING BARRIERS TO VACCINE WE
QUICKLY SAW A HUGE DROP IN CASES
AND THE ABILITY TO DECLARE
ELIMINATION.
JUST TO PROVIDE SOME
PERSPECTIVE.
AND THIS IS A SLIDE THAT SHOWS
WHERE WE GET OUR IMPORTATIONS
FROM.
SO PRIOR TO ELIMINATION MOST OF
OUR IMPORTATIONS WERE ACTUALLY
FROM THE AMERICAS.
SO IN ADDITION TO OUR TWO-DOSE
RECOMMENDATION AS WELL AS THE
VSC PROGRAM ORGANIZATION
SIMULTANEOUSLY COMMITTING TO
ELIMINATION DID A LOT TO HELP
REDUCE OUR IMPORTATIONS.
SO THEN THE IMPORTATIONS WERE
COMING FROM OTHER AREAS WHERE IT
IS INFLUENCED BY THE
EPIDEMIOLOGY AS WELL AS TRAVEL.
AS WE GOT INTO THE LATE 2000s
YOU CAN SEE IN THE RED MOST
CASES WERE COMING FROM EUROPE
AND SOME OF THE CHALLENGES THEY
WERE HAVING THERE.
THEN YOU CAN SEE THIS SORT OF
SHIFT TO THE REGION DOMINATED BY
THE PHILIPPINES THIS YEAR.
THERE IS LESS TRAVEL WITH CHINA
BUT CERTAINLY WHAT IS HAPPENING
THERE IS A CONCERN.
THIS SHOWS THE NUMBER OF CASES
REPORTED TO GET SOME
PERSPECTIVE.
SO AS WE CAME OUT OF THE
RESURGENCE IN 1993 AND STILL HAD
A MULTI-STATE OUTBREAK THAT
OCCURRED HERE WE START TO SEE
EVIDENCE OF A LACK OF ENDEMIC
TRANSMISSION.
AND THEN VERY QUICKLY A LOW
NUMBER OF CASES.
BUT NOW YOU START TO SEE
SOMETHING THAT LOOKS A LITTLE
BIT CONCERNING.
WE'LL TALK A LITTLE MORE ABOUT
THAT NOW.
SO IN THE HASHMARK IS THE NUMBER
OF IMPORTATIONS SINCE THE
DECLARATION OF ELIMINATION
FOLLOWED BY IN THE SOLID THE
NUMBER OF CASES THAT ARE NOT
DIRECT IMPORTS.
YOU CAN SEE IN 2008 WE DIDN'T
HAVE AN INCREASED NUMBER OF
IMPORTATIONS BUT A COUPLE OF
OUTBREAKS LED TO INCREASE IN
NUMBER OF CASES.
IN 2011 WE SAW A NUMBER OF
IMPORTATIONS.
THE NUMBER OF IMPORTATIONS IS
WHAT DOMINATED THAT.
WHILE THERE IS STILL A NUMBER OF
IMPORTATIONS IN 2013 THERE WERE
THREE OUTBREAKS THAT CONTRIBUTED
TO THAT TRANSMISSION.
IN 2014 YOU SEE A SIMILAR
PATTERN TO 2013 BUT IF YOU LOOK
AT THE BLACK LINE AND ABOVE THAT
IS ALL THE OUTBREAK IN OHIO.
ONE OUTBREAK OR A COUPLE OF
OUTBREAKS CAN INFLUENCE WHAT WE
SEE EACH YEAR.
THIS IS MAYBE A COMPLEX SLIDE.
THE BASIC POINT IS HOW MANY
IMPORTATIONS DO WE GET LEADS TO
HOW MANY CASES OF TRANSMISSION.
SO THE BOTTOM LINE IS AS WE
ENTERED ELIMINATION AND
MAINTAINED ELIMINATION THE BLUE
AND THE RED MOST OF OUR
IMPORTATIONS LEAD TO NO
TRANSMISSION OR TRANSMISSION TO
ONE PERSON AND OFTEN THESE ARE
SORT OF HOUSEHOLD TRANSMISSION.
BUT WE DO GET SOME THAT LEAD TO
TEN OR MORE CASES.
AND THIS YEAR THE MAJORITY OF
OUR CASES ARE ONLY ONE OR TWO
CASES OF LINKED TRANSMISSION,
BUT WE ARE SEEING SOME THAT ARE
TEN OR MORE WHICH IS MORE THAN
WE MAY HAVE SEEN IN THE PAST.
AND THIS IS JUST AGE SPECIFIC
INCIDENTS RATE.
I WANT YOU TO FOCUS ON THESE
COLORS RIGHT HERE.
AND THE POINT IS THAT WHENEVER
THERE IS AN INCREASE IN THE
NUMBER OF CASES IN THE UNITED
STATES THE INCIDENTS RATES THAT
GO UP ARE IN THE YOUNGER
CHILDREN.
THOSE ARE THE ONES WHO ARE MOST
VULNERABLE TO COMPLICATIONS,
SOME OF WHICH WERE TOO YOUNG TO
BE VACCINATED.
JUST TO BRIEFLY SUMMARIZE WHAT
IS HAPPENING IN THE UNITED
STATEVERAGE REMAINS HIGH.
THE VACCINE WORKS.
PUBLIC HEALTH DEPARTMENTS ARE
STILL TAKING A VERY AGGRESSIVE
STANCE OF CHASING EVERY SUSPECT
CASE TO TRY TO STOP THINGS.
EVEN WITH THE OHIO OUTBREAK IF
THE FIRST COUPLE OF CASES WOULD
HAVE BEEN CAUGHT YOU WOULDN'T
SEE THE TRANSMISSION WE ARE
SEEING NOW.
AND WE HAVE ALSO OVER THE LAST
FEW YEARS HAVE HAD QUITE
OF IMPROVEMENT HEALTH CARE
WORKER RECOMMENDATIONS AS WELL
AS IMPLEMENTATION AND ELECTRONIC
HEALTH RECORDS OF HOSPITAL STAFF
TO KEEP TRANSMISSION FROM
HAPPENING IN THOSE SETTINGS.
BUT WHAT ARE THE CHALLENGES?
IT'S REALLY IN COVERAGE.
WE HAVE GROUPS WHO HAVE A HIGH
ENOUGH PROPORTION OF PEOPLE WHO
DON'T GET VACCINATED AND ARE
STARTING TO ACCUMULATE OVER TIME
AND AGING OVER TIME.
EVEN WITH A SMALL PERCENT THEY
GROW.
WHAT HAPPENS GLOBALLY CERTAINLY
INFLUENCES WHAT HAPPENS HERE.
SO IMPORTATIONS ARE GOING TO
CONTINUE.
SO WE CAN'T SORT OF LET OUR
GUARD DOWN ON WHAT WE DO HERE IN
THE UNITED STATES.
REMEMBER MOST OF THOSE
IMPORTATIONS ARE U.S. RESIDENTS
WHO COULD HAVE BEEN VACCINATED
BEFORE THEY LEFT.
EARLY DIAGNOSIS OF INITIAL CASES
IS STILL A CHALLENGE AND HAS
CONSEQUENCES.
IT'S IMPORTANT TO THINK ABOUT
MEASLES WHEN YOU ARE THINKING
ABOUT OTHER RASH ILLNESSES IN
TRAVELERS.
THESE INITIAL PHILIPPINE
IMPORTATIONS INTO OHIO WERE
FIRST SUSPECTED TO BE DENGUE.
THAT IS A STORY WE HEAR OFTEN.
WITH CHILDREN WE HEAR ABOUT KIDS
BEING WORKED UP FOR KAWASAKI
DISEASE WHEN IT IS MEASLES.
RECOMMENDATIONS ARE THAT A CHILD
GET VACCINATED SIX MONTHS BEFORE
THEY TRAVEL.
I THINK THERE IS A LACK OF
AWARENESS AND IMPLEMENTATION OF
THAT.
AND FOR ADULTS WHO ARE NOW TOO
OLD TO HAVE BEEN RECOMMENDED TWO
DOSES WHO STILL ONLY REQUIRE ONE
DOSE IN THE UNITED STATES OR ARE
RECOMMENDED ONE DOSE IF THEY ARE
GOING TO TRAVEL THEY SHOULD HAVE
TWO DOSES BEFORE THEY TRAVEL.
AND THIS IS A RESOURCE INTENSIVE
PUBLIC HEALTH RESPONSE.
EVERY TIME THERE IS A CASE THE
PUBLIC HEALTH DEPARTMENTS HAVE
TO DIVERT RESOURCES TO TRY TO
STOP IT EARLY.
AND THIS IS RESOURCE INTENSIVE
AND THERE IS ALSO A CONCERN OF
MISSION FATIGUE AS THIS
CONTINUES.
SO THE KEY MESSAGES ARE MEASLES
IS A GLOBAL ISSUE FOR THE UNITED
STATES.
WE ARE GOING TO CONTINUE TO GET
IMPORTATIONS BUT WE CAN
INTERVENE WITH THOSE U.S.
TRAVELERS, AT LEAST AN
OPPORTUNITY TO.
MEASLES IS VERY CONTAGIOUS.
WHEN IT GETS INTO THE UNITED
STATES IT IS EVENTUALLY GIVEN
ENOUGH OPPORTUNITY TO FIND THE
POCKETS OF UNVACCINATED.
KEEP MEASLES IN THE DIFFERENTIAL
DIAGNOSIS, GET A TRAVEL HISTORY
OR EXPOSURE TO TRAVELERS,
VACCINE HISTORY AND AGE OF
ELIMINATION VIRAL SPECIMENS WITH
BE CRITICAL TO SORTING OUT
DIFFICULT SITUATIONS.
I WANT TO CLOSE WITH THE CONCEPT
OF WE HAVE ALWAYS TALKED ABOUT
POCKETS OF UNVACCINATED, WHO
THEY ARE, WHY THEY DON'T GET
VACCINATED.
I THINK WHAT MEASLES IS STARTING
TO REVEAL IN THE UNITED STATES
IS THAT THERE IS A HUGE VARIETY
OF GROUPS THAT DO NOT GET
VACCINATED.
EVERY YEAR WE ARE SEEING A
DIFFERENT GROUP THAT WE MAY NOT
HAVE CONSIDERED IN THE PAST.
AND THE INTERVENTION FOR THESE
GROUPS IS GOING TO HAVE TO BE
TAILORED FOR THE REASONS THAT
THEY MAY OR MAY NOT BE GETTING
VACCINATED.
THANK YOU.
JIM CAN COME UP AND WE CAN TAKE
THANK Y
PRESENTATIONS.
IT IS HUMBLING TO SEE WHAT CAN
HAPPEN.
I HAVE A QUICK QUESTION FOR YOU,
GREG.
I THINK YOU LAID OUT A CASE
PRETTY WELL THAT WHAT WE ARE
SEEING IN OHIO WITH THE KIND OF
UNFORTUNATE MIXTURE
UNVACCINATION.
ARE THERE EFFORTS WITH
REGISTRIES TO START MAPPING OUT
ACROSS THE COUNTRY POCKETS OF
HIGH RISK TO KIND OF PREEMPT
POTENTIAL OUTBREAKS?
THAT IS SOMETHING WE WANT TO
DO AND HAS HAD FITS AND STARTS
IN TRYING TO IMPLEMENT.
IT IS SOMETHING WE ARE VERY
INTERESTED IN.
WHAT I DIDN'T TALK ABOUT IS SOME
MODELING WORK WHERE WE CAN USE
THE REGISTRIES TO HELP HEALTH
DEPARTMENTS IN WHAT COULD BE THE
CONSEQUENCES OF WHAT THEY ARE
SEEING IN THEIR REGISTRY TO HELP
THEM GET NEEDED RESOURCES TO TRY
TO INTERVENE. YOU LOOK AT THE A
SCHEDULE IT SAYS FOR MEASLESN B
CONSIDERED ALL AFTER 1957 SHOULD
HAVENE OR MORE
DOSES OF VACCINE.
ARE YOU SAYING NOW THAT EVEN FOR
ADULTS BORN BEFORE 1957 THAT
JUST THAT AGE IS NOT ENOUGH,
THAT WE OUGHT TO BE DOING MORE
BEFORE THESE PATIENTS TRAVEL?
NO, SORRY.
I DIDN'T GO INTO THE DETAILS.
THE 1957 RECOMMENDATION STILL
HOLDS.
SO WHAT WE ARE TALKING ABOUT ARE
THOSE BORN AFTER THAT WHO HAVE
ONLY HAD ONE DOSE SHOULD GET A
SECOND DOSE BEFORE THEY TRAVEL.
THANKS FOR THAT CLARIFICATION.
>> THANKS.
SO IT IS HEARTENING ABOUT THE
REGIONAL ELIMINATION GOALS
THOUGH I THINK A CLOSE LOOK
SUGGESTS AT LEAST TWO OF THE
REGIONS WON'T MEET CURRENT THERE
DONE AND ONGOING RISK TO
TRAVELERS.
I AM CURIOUS GIVEN THE DATE YOU
HAVE SHOWN WHAT DONE TO
ENSURE U.S. TRAVELERS ARE IMMUNE
BEFORE THEY LEAVE SHORES AND
COME BACK.
BEYOND BASICALLY REITERATING
WHAT THE TRAVEL RECOMMENDATIONS
ARE WHENEVER THE SITUATIONS COME
UP WE TRY TO TAKE THE
OPPORTUNITY TO REINFORCE THAT
MESSAGE.
SO EVEN EARLY IN 2011 WHEN WE
WERE SEEING AN INCREASE IN
IMPORTATIONS A LOT OF THOSE
CASES WERE IN THE SORT OF 6 TO
15 MONTH OLDS.
A LOT OF TIMES YOUNG FAMILIES
ARE BRINGING THEIR CHILD BACK TO
THE COUNTRY FROM WHICH THEY
IMMIGRATED.
THAT CAN BE A SOURCE OF
IMPORTITATION.
SO JUST TRYING TO KEEP THAT
MESSAGE OUT THERE AND GET THAT
ACROSS.
WE ALSO WITH THE CURRENT
SITUATION ARE SPENDING A LOT OF
TIME DOING PHYSICIAN-BASED,
CLINICAL PROVIDER-BASED WEBINARS
AND DISCUSSIONS TO KEEP THIS ON
THEIR RADAR SCREEN.
WE ARE DOING MORE OF THAT THIS
YEAR, AS WELL, THROUGH
EDUCATION.
>> I THINK I SEE A COMMENT FROM
DR. SHUKEN.
>> JUST TO SAY WE HAVE SINCE
APRIL BEEN RAMPING UP THE
OUTREACH RELATED TO RISKS AND
TRAVELERS ON THE TRAVEL HEALTH
SITE ON THE WEB AS WELL AS THEIR
PARTNERS DID A LOT MORE.
IN ADDITION TO RISK IN THE
PHILIPPINES WE DID A LOT BECAUSE
OF THE WORLD CUP IN ADVANCE OF
THAT.
WHILE IT MAY OR MAY NOT HAVE
REACHED ALL OF THE TRAVELERS WE
HAVE HAD A LOT OF MEDIA UPTAKE
AND CLINICIAN OUTREACH TO TRY TO
GET TO TRAVELERS AND THEIR
CLINICIANS.
>> SO OUR DIVISION OF QUARANTINE
AND MIGRATION DOES A LOT AROUND
TRAVEL ALERTS AS WELL AS
EDUCATIONAL THINGS THAT APPEAR
AT THE AIRPORTS AND THE LIKE.
GO AHEAD.
>> JUST TO ADD BRIEFLY ON A LOT
OF THE -- A LOT OF WHAT WAS
DONE -- WAS IT IN NEWS TO TARGET
YOUNG CHILDREN WHO ARE TRULY
MISSED OPPORTUNITIES, 6 TO 11
MONTH OLDS AND 12 TO 15 MONTH
OLDS.
A LOT OF OUR TRAVELERS ARE
PERSONAL BELIEF EXEMPTERS.
A LOT OF PEOPL
INCLUDING THE TWO WHO CAME BACK
FROM THE PHILIPPINES INTO OHIO
HAD CHOSEN NOT TO BE VACCINATED
AFTER KNOWING THE
RECOMMENDATION.
OUR EFFORT IS TO COMMUNICATE ALL
WE CAN AND WORK TO TRY TO DEAL
WITH THE OTHER ISSUE.
>> I JUST WANTED TO ASK IF THIS
HASN'T BEEN DONE -- ALL OF THE
OUTBREAK S GOING ON IF YOU ARE
DISCOVERING NEW POCKETS THAT
WOULD BE HELPFUL TO ADVERTISE
THAT TO THE STATES SO WE CAN
START LOOKING AT THOSE POCKETS
TO THE STATES.
SOME OF THEM MAY BE PERSUADABLE.
THAT WOULD BE HELPFUL IF YOU ARE
DISCOVERING NEW GROUPS THAT WE
MAY NOT BE THINKING OF.
>> GO AHEAD.
AS YOU PROBABLY KNOW WE HAD A
CONFERENCE, A NATIONWIDE
CONFERENCE CALL LAST WEEK TO
ALERT ESPECIALLY ABOUT THIS
OUTBREAK IN OHIO WHICH IS IN THE
AMISH POPULATION.
PEOPLE KNOW THAT.
IT IS IN THE MEDIA.
THAT IS A VERY LARGE GROUP IN
MANY STATES.
SO WE ARE DOING ALL WE CAN WITH
THAT PARTICULAR POPULATION WHICH
IS HIGHLY AT RISK.
>> THANK YOU.
THANK YOU FOR THE PRESENTATION.
IN ORANGE COUNTY WHERE I WORK IN
CALIFORNIA WE HAVE HAD 22 CASES
OF MEASLES SINCE THE BEGINNING
OF THE YEAR.
AND FIVE OF THEM HAVE BEEN IN
HEALTH CARE WORKERS.
AND THE ISSUE WE RUN INTO IS BY
AND LARGE THEY ARE IMMUNIZED.
THEY HAVE TWO DOSES DOCUMENT AND
SEROLOGY DOCUMENTING THEY ARE
IMMUNE.
THE ISSUE IS THEY ARE CONSIDERED
IMMUNE SO THEY GO ABOUT WORKING.
THEY PROBABLY HAVE SOME
IMMUNITY.
SO IN THE FIRST FEW DAYS WITH
RUNNY NOSE AND COUGH THEY KEEP
WORKING AND SEEING PATIENT AFTER
PATIENT AFTER PATIENT.
IN TERMS OF MISSION FATIGUE IT
IS A LOT OF WORK FOR ALL OF
THESE RESPONSES.
WHEN YOU HAVE A HEALTH CARE
WORKER LIKE SOMEONE WHO WORKS IN
AN EMERGENCY ROOM AND FOUR DAYS
BEFORE THE RASH HAVE SEEN OVER
1,000 PATIENTS FACE-TO-FACE, NOT
JUST IN THE SAME BUILDING, SAME
AIR, THOSE ARE EXTREMELY
DIFFICULT RESPONSES.
SO ONE OF THE BIG EMPHASIS WE
HAVE BEEN TRYING TO GET OUT TO
HEALTH CARE PROVIDERS IS GET
IMMUNIZ
IMMUNIZED.
STILL PRACTICE PRECAUTIONS.
YOU ARE NOT 100% SURE TO BE
IMMUNE AND INFECTION RESPONSES
IS REALLY SIGNIFICANT IN THOSE
SITUATIONS.
>> AND IT IS AN IMPORTANT POINT,
TOO, TO ADD TO THAT.
IT INCLUDES EARLY RECOGNITION OR
SUSPICION SO YOU ISOLATE THE
PATIENT AS SOON AS POSSIBLE.
IT IS NOT UNCOMMON TO GET A CASE
IN THE HEALTH CARE SYSTEM FOR
SOME TIME BEFORE RECOGNIZED.
>> THAT IS ABSOLUTELY RIGHT.
THE PROVIDER SAYS I KNOW I'M
IMMUNE.
THEY ARE IN THAT NEGATIVE
PRESSURE ROOM.
I'M NOT GOING TO WEAR MY M 95
BECAUSE IT IS ANNOYING.
STUDIES HAVE SHOWN UP TO 70
PLUS PERCENT OF EMPLOYEES SHOW
UP TO WORK SICK AND KEEP
WORKING.
GO AHEAD.
>> WE WEREN'T TALKING TO EACH
OTHER BUT HAVE THE SAME
QUESTION.
RELATED TO THIS HEALTH CARE
WORKER TAKING CARE OF CHILDREN
IN MY CASE I SURVEYED ALL OF THE
CHILDREN'S HOSPITALS ACROSS THE
COUNTRY WHO ARE ON OUR INFECTION
PREVENTION DIRECTOR'S LIST.
SOME PEOPLE DO NOT WEAR MASKS
BECAUSE THEY ARE COUNTING ON
IMMUNITY.
SOME PEOPLE WERE SURGICAL MASKS.
SO SOME STATES HAVE VERY STRICT
OSHA LAWS AND OTHERS DON'T.
THIS WOULD BE AN AREA THAT WOULD
BE HELPFUL TO CLARIFY.
THOSE RECOMMENDATIONS ARE IN
OUR SURVEILLANCE MANUAL.
BUT I AGREE WHEN I HAVE BEEN
JUST RECENTLY TALKING TO
DIFFERENT HEALTH DEPARTMENTS Y U
DO GET A VARIETY OF RESPONSES ON
COMPLIANCE.
>> GO AHEAD.
THOSE ARE THE RECOMMENDATIONS
THAT ARE MADE.
ALSO AND THE 2013
RECOMMENDATIONS IS THAT A HEALTH
CARE WORKER WITH EVIDENCE OF
IMMUNITY WITH TWO DOSES SHOULD
BE PROTECTED WHEN ENTERING A
ROOM.
WE NEED TO GET THE MESSAGE OUT.
WE HAVE TAKEN THE QUESTIONS
QUITE A LOT THIS YEAR BECAUSE OF
THE TWO DOSE PHASES THAT WILL
OCCUR SOMETIMES.
THANK YOU.
DR. KEMP.
>> I JUST FEEL I WOULD BE
REMISED AND I NOTICED NO ONE
ELSE IS GOING THERE TO TALK
ABOUT THE POCKETS OF UNDER
VACCINATED CHILDREN ESPECIALLY
WHEN WHETHER YOU COULD COMMENT
ON WHETHER DECREASING PERSONAL
EXEMPTION WOULD HAVE MADE MUCH
OF A DIFFERENCE IN THESE CASES
OR OTHER PROPOSED POLICY
REGULATIONS LIKE PUBLISHING THE
CHILDREN IN PRESCHOOLS AND
SCHOOLS ET CETERA TO MORE
AGGRESSIVE MEANS OF DECREASING
UNDER VACCINATION?
SO WHEN I TALKED ABOUT THE
CONTRIBUTIONS TO ELIMINATION I
TALKED ABOUT EFFORTS TO
ELIMINATE WITHIN THE AMERICAS
AND THE PROGRAM REMOVING
BARRIERS AS WELL AS TWO DOSE
RECOMMENDATION ANOTHER IMPORTANT
PART OF THAT WAS SCHOOL LAWS AND
HAVING THAT SECOND DOSE SCHOOL
BASED RECOMMENDATION WHERE
PEOPLE GOT CAUGHT UP BEFORE
THERE WAS A LOT OF MIXING THAT
WAS CRITICAL TO WHAT WE WERE
ABLE TO DO IN THE UNITED STATES
AND WHAT OTHER NATIONS HAVE NOT
BEEN ABLE TO DO BECAUSE OF THEIR
UNWILLINGNESS TO DO SCHOOL BASED
SCHOOL LAWS BASICALLY.
SO I THINK YOU'RE RIGHT THERE
HAS BEEN LOT OF BATTLE BACK AND
FORTH EVERY YEAR IN PROBABLY
ALMOST EVERY STATE WHERE THE
DEGREE OF EASE CAN GO -- AT
LEAST ANECDOTALLY IF THE ABILITY
IS MADE TO OPT OUT THAT HELPS.
I THINK THAT IS DEFINITELY AN
AREA WHERE WE CONTINUE TO FIGHT
AND HAS WORKED FIGHTING.
OTE OR
QUESTIONS?
I'LL JUST TAKE A MOMENT TO
FOLLOW UP ON THAT A LITTLE BIT.
IT DOES SEEM LIKE THERE HAS BEEN
A MOMENTUM CHANGE IN VACCINE
ACCEPTANCE IN THE LAST COUPLE OF
YEARS.
OTHER GROUPS THAT ARE
PHILOSOPHICAL EXEMPTERS OR NOT
ACCEPTING A VACCINE, I THINK
WHAT WE HAVE SEEN IN A COUPLE OF
DOMESTIC OUTBREAKS IS IN
COMMUNITIES WHERE YOU HAVE
SEEN -- WE HAVE SEEN IT IN A
NUMBER OF OUTBREAKS HERE.
THAT IS IMPORTANT TO KEEP IN
MIND THAT THERE IS QUITE A
CONTINUUM OF FOLKS IN THAT
CATEGORY.
I THINK BETTER UNDERSTANDING WHO
THOSE GROUPS ARE WOULD BE
HELPFUL.
>> DR. PICKERING.
GREG, YOU MADE THE
RECOMMENDATIONS FOR CHILDREN WHO
TRAVELLED INTERNATIONALLY DOWN
TO 6 MONTHS OF AGE SHOULD GET
MEASLES IMMUNIZATION.
ARE YOU IMPLEMENTING THOSE
RECOMMENDATIONS IN THESE
COMMUNITIES WHERE THERE ARE
OUTBREAKS?
>> AS FAR AS GOING DOWN TO 6
MONTHS OF AGE THAT HAS HAPPENED
IN LIMITED SITUATIONS.
IT IS A LOCAL DECISION.
SO IF THE EPIDEMIOLOGY OF THE
OUTBREAK THAT THEY ARE
EXPERIENCING WITHIN THE UNITED
STATES INDICATES THAT THERE ARE
TIMES WHEN WE DO THAT FIRST DOSE
EARLY DOWN TO SIX MONTHS.
IN 2011 IN MINNESOTA AND IN THE
DISTRIBUTION HAPPENING IN SOME
HOMELESS SHELTERS THAT DID
OCCUR.
AS FAR AS THAT SECOND DOSE EARLY
BEFORE AGE 4 TO 6 THERE IS NO
CON TRAINDICATION OF DOING THAT.
WHEN THE EPIDEMIOLOGY HAS
POINTED IN THAT DIRECTION
SOMETIMES IT IS A QUESTION OF
RESOURCES.
FIRST PRIORITIZUATION IS TO GET
THOSE WITH NO DOSE TO GET ONE
DOSE.
CERTAINLY TO GET THE SECOND DOSE
EARLY BEFORE 4 TO 6 IS SOMETHING
COMPLETELY ACCEPTABLE EVEN WHEN
THERE IS NOT AN OUTBREAK.
GOING TO 6 MONTHS IS SOMETHING
WE RESERVE WHEN EPIDEMIOLOGY
DEMANDS THAT BASICALLY.
AND JUST TO COMMENT ABOUT
EARLY VACCINATION WITH MEASLES
AT 6 MONTHS.
GLOBALLY W.H.O. RECOMMENDS THAT
YOU START AT 6 MONTHS OF AGE FOR
VACCINATION FOR OUTBREAK
RESPONSE.
THE CHALLENGE IS THAT EARLY
DOSES SHOULD NOT COUNT TOWARDS
THE TWO DOSES THAT ALL CHILDREN
NEED.
WHEN A MOTHER GETS VACCINATION
SHE NEEDS TO BE REMINDED THAT
THE CHILD NEEDS TO COME BACK TO
RECEIVE TWO REGULARLY SCHEDULED
DOSES.
THE VACCINE EFFECTIVENESS AT 6
MONTHS OF AGE IS REDUCED TO 50%
TO 60%.
EVEN THOUGH THEY ARE VACCINATED
ARE NOT PROTECTED, A LARGE CHUNK
OF THEM.
JUST TO ADD TO THAT.
>> OKAY.
THANK YOU VERY, VERY MUCH.
>>> I THINK WE ARE GOING TO TAKE